New “Obesity Fighting” Drug That Claims to Cut Body Weight by Up to 20 Percent

People have been looking for weight loss in a pill for ages. The issue is whether this drug will have any major side effects on certain people, and if it does, whether those side effects are worth the benefits of weight loss. The natural way to lose weight is to simply burn more calories than you consume, thus entering what’s known as a caloric deficit. The importance of “calories in, calories out,” is not emphasized enough in our systems of education, and it is a massive detriment to the population that that’s the case. In the trial, one of the people began gaining weight after the administration of the drug stopped, and that shows how losing weight remains an issue to address outside of medically-supervised drug usage. Additionally, I have to question how much of the weight loss was from the drug when the participants of the trial were also supposedly eating less and doing more exercise.

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The drug – semaglutide – hijacks the body’s appetite regulating system in the brain, leading to reduced hunger and calorie intake.

Rachel Batterham, professor of obesity, diabetes and endocrinology who leads the Centre for Obesity Research at UCL and the UCLH Centre for Weight Management, said: “The findings of this study represent a major breakthrough for improving the health of people with obesity.

“Three quarters (75%) of people who received semaglutide 2.4mg lost more than 10% of their body weight and more than one-third lost more than 20%.

The professor, who is one of the principal authors on the paper, added: “No other drug has come close to producing this level of weight loss – this really is a game-changer.

“For the first time, people can achieve through drugs what was only possible through weight-loss surgery.”

The drug will soon be submitted for regulatory approval as a treatment for obesity to the National Institute of Clinical Excellence (NICE), the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

As well as the drug, participants received individual face-to-face or phone counselling sessions from registered dietitians every four weeks to help them adhere to the reduced-calorie diet and increased physical activity.

They also received incentives such as kettle bells or food scales to mark progress and milestones.

A placebo group observed an average weight loss of 2.6kg (0.4 stone) with a reduction in BMI of minus 0.92.

Semaglutide is clinically approved to be used for patients with type 2 diabetes, but they are prescribed a lower dose.

Teenagers With Better Childhoods Drink Less and Do Drugs Less

If we structured a system where there was less poverty and despair, more people would have better childhoods, and less people would end up with damaging drug addictions.

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Teenagers with happy childhood memories are likely to drink less, take fewer drugs and enjoy learning, according to research published in the peer-reviewed journal Addiction Research & Theory.

The findings, based on data from nearly 2,000 US high school students, show a link between how pupils feel about the past, present and future and their classroom behavior. This in turn influences their grades and risk of substance misuse, according to the study.

The authors say action is needed now because Covid-19 has left many teenagers struggling with online study, suffering mentally and turning to drink and drugs.

They are calling on teachers — and parents — to help students develop more positive mindsets and become motivated to learn so they are less likely to binge drink or use marijuana.

“School often seems a source of stress and anxiety to students,” says John Mark Froiland from Purdue University in Indiana, US.

“This puts them at greater risk of not participating in lessons, getting lower grades and of substance misuse.

“Many teenagers also aren’t engaging with online learning during Covid or have lower engagement levels.

“But they’re more likely to be enthusiastic learners and not use drink and drugs if teachers take time to build more positive relationships with them. They can help students see that everything they’re learning is truly valuable. Parents have a role to play too.”

Teenagers with a balanced attitude towards their childhoods and other time periods have already been shown by studies to be more likely to abstain from drink and drugs and achieve academically. This is compared to those with a pessimistic outlook.

The aim of this study was to establish how substance misuse and behaviors towards learning are affected by students’ feelings about the past, present and future.

The data was based on assessments and questionnaires completed by 1,961 students at a high school in the San Francisco Bay Area. More than half (53%) of the pupils included in the study were female.

The study authors looked at responses from pupils where they rated how nostalgic they were towards their childhood, current happiness levels in life and how much they look forward to future happiness.

They also analysed marijuana and alcohol habits over the past 30 days including binge drinking, and average academic grades. They analysed motivation levels, and behavior in lessons such as how much teenagers paid attention and listened.

Statistical techniques were used by the researchers to assess the associations between all these different factors and establish the key predictors for alcohol and marijuana misuse.

In general, the study found that positive attitudes towards the past, present and future put adolescents at lower risk for alcohol use, binge drinking, and marijuana.

The opposite was true for those displaying pessimistic or negative ways of thinking or feeling about their life in the past, now or ahead of them.

The reason for this was that a content and optimistic outlook increased the likelihood they would be motivated and behave in a focused way on the chance to learn.

Other findings include girls having stronger levels of behavioral engagement than boys, and students who drank being most likely to use cannabis.

Important COVID-19 Antibody Drugs Aren’t Being Used Enough

“Antibody drugs from Regeneron and Eli Lilly could reduce hospitalizations from Covid-19 by 50-70%,” as the article says.

When President Donald Trump got sick with Covid-19 in October, he credited an antibody drug from Regeneron with making him feel better “immediately.”

“I felt as good three days ago as I do now,” he said in a video shot in front of the White House after he left Walter Reed National Military Medical Center, promising medicines from Regeneron and Eli Lilly would soon be available to the American public to help stop the terrible effects of Covid-19.

The concern, as these drugs were cleared through the FDA and made it to market last month, was that there wouldn’t be enough supply. They’re complicated to manufacture, and Regeneron said there were only enough doses for 80,000 Americans by the end of November. Lilly has 250,000 doses available.

An average of more than 200,000 Americans are currently getting diagnosed with Covid-19 every day, according to data compiled by Johns Hopkins University. Policymakers expected to need to ration the antibody drugs.

But a month into their distribution, the opposite problem has emerged: the drugs are not getting used.

“We have a surplus of these monoclonal antibodies right now,” Health Secretary Alex Azar told CNBC’s Shepard Smith Tuesday night. “What’s happening is people are waiting too long to seek out the treatments.”

Moncef Slaoui, chief scientific adviser to the U.S. government’s Operation Warp Speed, told CNBC Tuesday that the federal government is distributing about 65,000 doses of the antibody drugs every week to states.

But, he said, only 5% to 20% of the doses are getting administered to patients.

“It should be used much more,” Slaoui said in a telephone interview, noting the drugs — which are indicated for patients at high risk for severe Covid-19 — could cut down on hospitalizations by 50% to 70%.

The drugs are not simple to administer. For one thing, they’re given by intravenous infusion, so patients must go to health centers where this can be done. But since they’re likely contagious, existing IV facilities, like where patients receive chemotherapy, can’t be used.

Another issue is that the drugs need to be given early in the course of the disease. The FDA’s guidance for health-care providers says they should be administered as soon as possible after diagnosis, and within 10 days of symptom onset. It recommends against use of the drugs once patients are so sick they’re hospitalized.

But many patients don’t feel sick right away, so the idea of an IV-infused drug doesn’t occur to them immediately after diagnosis, Slaoui and Azar suggested.

“If you are over 65 or at risk of serious complications or hospitalization due to co-morbidities, what have you, and you test positive, you need to seek out and get the Lilly or Regeneron monoclonal antibody,” Azar said on the “News With Shepard Smith.” “It can dramatically reduce the risk for us of hospitalizations at a time when hospitals are getting very crowded with people with Covid.”

But it’s a challenge for some health systems to set up the infrastructure to deliver these drugs. Some states are using 100% of their allocation, Slaoui said. Others, like in Georgia and Illinois, may not be using any, according to former FDA Commissioner Dr. Scott Gottlieb.

Georgia’s public health department didn’t immediately respond to questions about their antibody usage. A spokeswoman for Illinois’ Department of Public Health said providers aren’t yet required to report use of monoclonal antibodies, but that the U.S. Department of Health and Human Services will require hospitals to report the information starting Jan. 8.

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He noted the data behind the medicines suggest “the number needed to treat in terms of keeping one patient out of the hospital … is 10.” Lilly has said it will have 950,000 doses available by the end of January, Gottlieb cited the effects if 900,000 doses were used: “That means if all of the drugs got distributed, we could avoid 90,000 hospitalizations or emergency room visits. That would be substantial.”

Lilly noted the IV administration of the antibody drugs “presents unique challenges to the healthcare system,” and said it’s working to address the challenges to ensure patients who need the drug can get it. The company is running a number of pilot programs through Operation Warp Speed, including one with CVS for in-home infusions, a company spokeswoman said.

Experimental Drug Quickly Reduces Age-Related Mental Decline

The compound, known as ISRIB, holds potential for reversing numerous cognitive problems in humans. Mice are used in scientific studies due to having genes that are approximately 85 percent similar to the genes of humans.

Just a few doses of an experimental drug can reverse age-related declines in memory and mental flexibility in mice, according to a new study by UC San Francisco scientists. The drug, called ISRIB, has already been shown in laboratory studies to restore memory function months after traumatic brain injury (TBI), reverse cognitive impairments in Down Syndrome, prevent noise-related hearing loss, fight certain types of prostate cancer, and even enhance cognition in healthy animals.

In the new study, published December 1, 2020 in the open-access journal eLife, researchers showed rapid restoration of youthful cognitive abilities in aged mice, accompanied by a rejuvenation of brain and immune cells that could help explain improvements in brain function.

“ISRIB’s extremely rapid effects show for the first time that a significant component of age-related cognitive losses may be caused by a kind of reversible physiological ‘blockage’ rather than more permanent degradation,” said Susanna Rosi, PhD, Lewis and Ruth Cozen Chair II and professor in the departments of Neurological Surgery and of Physical Therapy and Rehabilitation Science.

“The data suggest that the aged brain has not permanently lost essential cognitive capacities, as was commonly assumed, but rather that these cognitive resources are still there but have been somehow blocked, trapped by a vicious cycle of cellular stress,” added Peter Walter, PhD, a professor in the UCSF Department of Biochemistry and Biophysics and a Howard Hughes Medical Institute investigator. “Our work with ISRIB demonstrates a way to break that cycle and restore cognitive abilities that had become walled off over time.”

Could Rebooting Cellular Protein Production Hold the Key to Aging and Other Diseases?

Walter has won numerous scientific awards, including the Breakthrough, Lasker and Shaw prizes, for his decades-long studies of cellular stress responses. ISRIB, discovered in 2013 in Walter’s lab, works by rebooting cells’ protein production machinery after it gets throttled by one of these stress responses — a cellular quality control mechanism called the integrated stress response (ISR; ISRIB stands for ISR InhiBitor).

The ISR normally detects problems with protein production in a cell — a potential sign of viral infection or cancer-promoting gene mutations — and responds by putting the brakes on cell’s protein-synthesis machinery. This safety mechanism is critical for weeding out misbehaving cells, but if stuck in the on position in a tissue like the brain, it can lead to serious problems, as cells lose the ability to perform their normal activities, Walter and colleagues have found.

In particular, recent animal studies by Walter and Rosi, made possible by early philanthropic support from The Rogers Family Foundation, have implicated chronic ISR activation in the persistent cognitive and behavioral deficits seen in patients after TBI, by showing that, in mice, brief ISRIB treatment can reboot the ISR and restore normal brain function almost overnight.

The cognitive deficits in TBI patients are often likened to premature aging, which led Rosi and Walter to wonder if the ISR could also underlie purely age-related cognitive decline. Aging is well known to compromise cellular protein production across the body, as life’s many insults pile up and stressors like chronic inflammation wear away at cells, potentially leading to widespread activation of the ISR.

“We’ve seen how ISRIB restores cognition in animals with traumatic brain injury, which in many ways is like a sped-up version of age-related cognitive decline,” said Rosi, who is director of neurocognitive research in the UCSF Brain and Spinal Injury Center and a member of the UCSF Weill Institute for Neurosciences. “It may seem like a crazy idea, but asking whether the drug could reverse symptoms of aging itself was just a logical next step.”

ISRIB Improves Cognition, Boosts Neuron and Immune Cell Function

In the new study, researchers led by Rosi lab postdoc Karen Krukowski, PhD, trained aged animals to escape from a watery maze by finding a hidden platform, a task that is typically hard for older animals to learn. But animals who received small daily doses of ISRIB during the three-day training process were able to accomplish the task as well as youthful mice, much better than animals of the same age who didn’t receive the drug.

The researchers then tested how long this cognitive rejuvenation lasted and whether it could generalize to other cognitive skills. Several weeks after the initial ISRIB treatment, they trained the same mice to find their way out of a maze whose exit changed daily — a test of mental flexibility for aged mice who, like humans, tend to get increasingly stuck in their ways. The mice who had received brief ISRIB treatment three weeks before still performed at youthful levels, while untreated mice continued to struggle.

To understand how ISRIB might be improving brain function, the researchers studied the activity and anatomy of cells in the hippocampus, a brain region with a key role in learning and memory, just one day after giving animals a single dose of ISRIB. They found that common signatures of neuronal aging disappeared literally overnight: neurons’ electrical activity became more sprightly and responsive to stimulation, and cells showed more robust connectivity with cells around them while also showing an ability to form stable connections with one another usually only seen in younger mice.

The researchers are continuing to study exactly how the ISR disrupts cognition in aging and other conditions and to understand how long ISRIB’s cognitive benefits may last. Among other puzzles raised by the new findings is the discovery that ISRIB also alters the function of the immune system’s T cells, which also are prone to age-related dysfunction. The findings suggest another path by which the drug could be improving cognition in aged animals, and could have implications for diseases from Alzheimer’s to diabetes that have been linked to heightened inflammation caused by an aging immune system.

“This was very exciting to me because we know that aging has a profound and persistent effect on T cells and that these changes can affect brain function in the hippocampus,” said Rosi. “At the moment, this is just an interesting observation, but it gives us a very exciting set of biological puzzles to solve.

ISRIB May Have Wide-Ranging Implications for Neurological Disease

It turns out that chronic ISR activation and resulting blockage of cellular protein production may play a role in a surprisingly wide array of neurological conditions. Below is a partial list of these conditions, based on a recent review by Walter and colleague Mauro Costa-Mattioli of Baylor College of Medicine, which could potentially be treated with an ISR-resetting agent like ISRIB:

  • Frontotemporal Dementia
  • Alzheimer’s Disease
  • Amyotrophic Lateral Sclerosis (ALS)
  • Age-related Cognitive Decline
  • Multiple Sclerosis
  • Traumatic Brain Injury
  • Parkinson’s Disease
  • Down Syndrome
  • Vanishing White Matter Disorder
  • Prion Disease

ISRIB has been licensed by Calico, a South San Francisco, Calif. company exploring the biology of aging, and the idea of targeting the ISR to treat disease has been picked up by other pharmaceutical companies, Walter says.

One might think that interfering with the ISR, a critical cellular safety mechanism, would be sure to have serious side effects, but so far in all their studies, the researchers have observed none. This is likely due to two factors, Walter says. First, it takes just a few doses of ISRIB to reset unhealthy, chronic ISR activation back to a healthier state, after which it can still respond normally to problems in individual cells. Second, ISRIB has virtually no effect when applied to cells actively employing the ISR in its most powerful form — against an aggressive viral infection, for example.

Naturally, both of these factors make the molecule much less likely to have negative side effects — and more attractive as a potential therapeutic. According to Walter: “It almost seems too good to be true, but with ISRIB we seem to have hit a sweet spot for manipulating the ISR with an ideal therapeutic window.

Experimental Drugs Reverse Arthritis in Rats Study

The science shows potential results in treating a debilitating condition.

People with osteoarthritis, or “wear and tear” arthritis, have limited treatment options: pain relievers or joint replacement surgery. Now, Salk researchers have discovered that a powerful combination of two experimental drugs reverses the cellular and molecular signs of osteoarthritis in rats as well as in isolated human cartilage cells. Their results were published in the journal Protein & Cell on January 16, 2020.

“What’s really exciting is that this is potentially a therapy that can be translated to the clinic quite easily,” says Juan Carlos Izpisua Belmonte, lead author and a professor in Salk’s Gene Expression Laboratory. “We are excited to continue refining this promising combination therapy for human use.”

Affecting 30 million adults, osteoarthritis is the most common joint disorder in the United States and its prevalence is expected to rise in coming years due to the aging population and increasing rate of obesity. The disease is caused by gradual changes to cartilage that cushions bones and joints. During aging and repetitive stress, molecules and genes in the cells of this articular cartilage change, eventually leading to the breakdown of the cartilage and the overgrowth of underlying bone, causing chronic pain and stiffness.

Previous research had pinpointed two molecules, alpha-KLOTHO and TGF beta receptor 2 (TGFβR2), as potential drugs to treat osteoarthritis. αKLOTHO acts on the mesh of molecules surrounding articular cartilage cells, keeping this extra-cellular matrix from degrading. TGFβR2 acts more directly on cartilage cells, stimulating their proliferation and preventing their breakdown.

While each drug alone had only moderately curbed osteoarthritis in animal models of the disease, Izpisua Belmonte and his colleagues wondered if the two drugs would act more effectively in concert.

“We thought that by mixing these two molecules that work in different ways, maybe we could make something better,” says Paloma Martinez-Redondo, a Salk postdoctoral fellow and co-first author of the new study.

The researchers treated young, otherwise healthy rats with osteoarthritis with viral particles containing the DNA instructions for making αKLOTHO and TGFβR2.

Six weeks after the treatment, rats that had received control particles had more severe osteoarthritis in their knees, with the disease progressing from stage 2 to stage 4. However, rats that had received particles containing αKLOTHO and TGFβR2 DNA showed recovery of their cartilage: the cartilage was thicker, fewer cells were dying, and actively proliferating cells were present. These animals’ disease improved from stage 2 to stage 1, a mild form of osteoarthritis, and no negative side effects were observed.

“From the very first time we tested this drug combination on just a few animals, we saw a huge improvement,” says Isabel Guillen-Guillen, the paper’s co-first author. “We kept checking more animals and seeing the same encouraging results.”

Further experiments revealed 136 genes that were more active and 18 genes that were less active in the cartilage cells of treated rats compared to control rats. Among those were genes involved in inflammation and immune responses, suggesting some pathways by which the combination treatment works.

To test the applicability of the drug combination to humans, the team treated isolated human articular cartilage cells with αKLOTHO and TGFβR2. Levels of molecules involved in cell proliferation, extra-cellular matrix formation and cartilage cell identity all increased.

“That’s not the same as showing how these drugs affect the knee joint in humans, but we think it’s a good sign that this could potentially work for patients,” says Martinez-Redondo.

The research team plans to develop the treatment further, including investigating whether soluble molecules of the αKLOTHO and TGFβR2 proteins can be taken directly, rather than administered through viral particles. They also will study whether the combination of drugs can prevent the development of osteoarthritis before symptoms develop.

“We think that this could be a viable treatment for osteoarthritis in humans,” says Pedro Guillen, director of the Clinica CEMTRO and co-corresponding author.

America’s Economy Outside of Unemployment and GDP

It’s rather striking that median male wages in America are 3 percent lower today than they were 40 years ago. Where the hell is the societal progress with damning statistics like that? And other stats worth mentioning are that 75 percent of Americans live paycheck to paycheck while their country’s child poverty rate is well over 20 percent. It is rather appalling that people are saying that America’s economy is booming.

As the world’s business elites trek to Davos for their annual gathering, people should be asking a simple question: Have they overcome their infatuation with US President Donald Trump?

Two years ago, a few rare corporate leaders were concerned about climate change, or upset at Trump’s misogyny and bigotry. Most, however, were celebrating the president’s tax cuts for billionaires and corporations and looking forward to his efforts to deregulate the economy. That would allow businesses to pollute the air more, get more Americans hooked on opioids, entice more children to eat their diabetes-inducing foods, and engage in the sort of financial shenanigans that brought on the 2008 crisis.

Today, many corporate bosses are still talking about the continued GDP growth and record stock prices. But neither GDP nor the Dow is a good measure of economic performance. Neither tells us what’s happening to ordinary citizens’ living standards or anything about sustainability. In fact, US economic performance over the past four years is Exhibit A in the indictment against relying on these indicators.

To get a good reading on a country’s economic health, start by looking at the health of its citizens. If they are happy and prosperous, they will be healthy and live longer. Among developed countries, America sits at the bottom in this regard. US life expectancy, already relatively low, fell in each of the first two years of Trump’s presidency, and in 2017, midlife mortality reached its highest rate since World War II. This is not a surprise, because no president has worked harder to make sure that more Americans lack health insurance. Millions have lost their coverage, and the uninsured rate has risen, in just two years, from 10.9% to 13.7%.

One reason for declining life expectancy in America is what Anne Case and Nobel laureate economist Angus Deaton call deaths of despair, caused by alcohol, drug overdoses, and suicide. In 2017 (the most recent year for which good data are available), such deaths stood at almost four times their 1999 level.

The only time I have seen anything like these declines in health—outside of war or epidemics—was when I was chief economist of the World Bank and found out that mortality and morbidity data confirmed what our economic indicators suggested about the dismal state of the post-Soviet Russian economy.

Trump may be a good president for the top 1%—and especially for the top 0.1%—but he has not been good for everyone else. If fully implemented, the 2017 tax cut will result in tax increases for most households in the second, third, and fourth income quintiles.

Given tax cuts that disproportionately benefit the ultrarich and corporations, it should come as no surprise that there was no significant change in the median US household’s disposable incomebetween 2017 and 2018 (again, the most recent year with good data). The lion’s share of the increase in GDP is also going to those at the top. Real median weekly earnings are just 2.6% above their level when Trump took office. And these increases have not offset long periods of wage stagnation. For example, the median wage of a full-time male worker (and those with full-time jobs are the lucky ones) is still more than 3% below what it was 40 years ago. Nor has there been much progress on reducing racial disparities: in the third quarter of 2019, median weekly earnings for black men working full-time were less than three-quarters the level for white men.

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And despite Trump’s vaunted promises to bring manufacturing jobs back to the US, the increase in manufacturing employment is still lower than it was under his predecessor, Barack Obama, once the post-2008 recovery set in, and is still markedly below its pre-crisis level. Even the unemployment rate, at a 50-year low, masks economic fragility. The employment rate for working-age males and females, while rising, has increased less than during the Obama recovery, and is still significantly below that of other developed countries. The pace of job creation is also markedly slower than it was under Obama.

Again, the low employment rate is not a surprise, not least because unhealthy people can’t work. Moreover, those on disability benefits, in prison—the US incarceration rate has increased more than sixfold since 1970, with some two million people currently behind bars – or so discouraged that they are not actively seeking jobs are not counted as “unemployed.” But, of course, they are not employed. Nor is it a surprise that a country that doesn’t provide affordable childcare or guarantee family leave would have lower female employment—adjusted for population, more than ten percentage points lower—than other developed countries.

Abortion Reversal — The Dangerous Practice You’ve Probably Never Heard Of

In the United States, many more laws have been implemented that restrict or ban a woman’s ability to have an abortion. Abortion reversal is a new technique that hasn’t undergone much medical testing since the one test on it showed significant harm to the women.

Several states now require women who seek medication abortions to be provided with dubious information that the procedure could be stopped, allowing a pregnancy to continue.

But when researchers attempted to carry out a legitimate study of whether these “abortion reversal” treatments were effective and safe, they had to stop almost immediately – because some of the women who participated in the study experienced dangerous hemorrhaging that sent them to the hospital.

By passing these abortion reversal laws, “states are encouraging women to participate in an unmonitored experiment,” Creinin said.

Creinin and his colleagues detailed their concerns in a commentary in the journal Contraception, and they will publish their study in January’s edition of Obstetrics and Gynecology.

Medication abortions, which are used up to 10 weeks into a pregnancy, consist of taking two pills in sequence. The first pill in the regimen, mifepristone, loosens the pregnancy’s attachment to the uterus. The second pill, misoprostol, forces the uterus to contract to push out the pregnancy. The pills must be taken consecutively to complete the abortion, and there’s a chance the pregnancy will continue if the second pill is not taken.

A total of 862,320 abortions were provided in clinical settings in 2017, according to the Guttmacher Institute, about 39 percent of which were medication abortions. Research has shown that using these drugs is a safe way to end a pregnancy.

Some antiabortion activists and legislators claim that not taking the second pill, or giving a woman high doses of the hormone progesterone after taking mifepristone, can help stop, or “reverse,” a medical abortion.

The American College of Obstetricians and Gynecologists firmly states that “claims regarding abortion ‘reversal’ treatment are not based on science and do not meet clinical standards” and say the purported studies that underpin these antiabortion arguments lack scientific rigor and ethics.

Despite this, the claims made in these discredited studies have worked their way to antiabortion lawmakers, who in turn have put them into abortion reversal legislation that was signed by governors in North Dakota, Idaho, Utah, South Dakota, Kentucky, NebraskaOklahoma and Arkansas. The laws are currently blocked or enjoined in Oklahoma and North Dakota.

Because reliable research on these treatments is nonexistent, earlier this year, Creinin and his colleagues designed a legitimate double-blind, placebo-controlled, randomized trial that aimed to observe 40 volunteers who had already elected to have a surgical abortion.

Their goal was to see if giving progesterone to women who took the first pill in the prescribed regimen would effectively and safely halt an abortion.

After the women took the first pill in the abortion protocol, mifepristone, rather than take the second pill, misoprostol, they were either given a placebo or a dose of progesterone.

Researchers only enrolled 12 women before they had to stop the study.

Bleeding is normal during a medication abortion. But three of the women who enrolled in the UC-Davis study experienced far more serious bleeding than anyone could have anticipated when the second pill was not administered.

One woman “was so scared she called an ambulance,” while another woman startled by the amount of blood “called 911 and crawled into her bathtub”, Creinin said. A third woman who went to the emergency room needed a transfusion. One of the women had received a placebo, while two others had taken the progesterone.

Creinin and his colleagues halted the study as soon as it became clear that they could not proceed safely.

“I feel really horrible that I couldn’t finish the study. I feel really horrible that the women … had to go through all this,” Creinin said. Because the study ended prematurely, the researchers could not establish any evidence that progesterone was an effective way to stop a medication abortion.

“What the results do show, though, is that there’s a very significant safety signal” when it comes to disrupting the approved medication abortion protocol, Creinin said.

In their upcoming paper in Obstetrics and Gynecology, the researchers warn that “patients in early pregnancy who use only mifepristone may be at high risk of significant hemorrhage.”

Medical experts are so concerned about abortion reversal laws that the American Medical Association joined a lawsuit against North Dakota’s abortion reversal law, which was blocked by a federal judge in September.

The North Dakota abortion reversal law, signed by Gov. Doug Burgum (R) in March, instructed health-care providers to tell a woman “that it may be possible to reverse the effects of an abortion-inducing drug if she changes her mind, but time is of the essence” and to provide a woman with literature on how to do this. The law fails to specify what that literature would include, or what such a treatment might entail.

Some Drug Company Executives Criminally Charged in America’s Flawed Democracy

A major producer of opioids known as the Rochester Drug Cooperative has recently witnessed its executives criminally charged with illegally distributing controlled substances. With the prosecution of corporate criminals at a 20 year low in America, amidst a major wave of corporate crime — crime in the suites instead of crime in the streets — it is a notable development during the despair-ridden opioid crisis.

Much of this opioid crisis is attributable to the patent monopolies on prescription drugs, which enable American pharmaceutical companies to charge ridiculously high prices. A patent monopoly on a drug legally prevents competitors from producing or selling that drug, and the lack of governmental negotiation to rein in prices allows pharmaceutical companies to charge to a large extent whatever they want. Purdue Pharma would have had nowhere near as much incentive to market Oxycontin if it was sold at generic prices, but since they had a tremendous incentive, many communities have suffered as a result of the addictive drug.

The case of patent monopolies on prescription drugs such as Oxycontin is another example of the government using its power in a way that’s overall against the public interest. The government is not necessarily an evil or inefficient entity, as people sometimes believe or that propaganda might suggest. There is plenty of evidence that structured properly, the government can be a force for the common good — government-run programs such as Medicare and Social Security remain popular because they work well. The administrative overhead on Medicare is about 2 percent, while the administrative overhead on corporate health insurance is often 12 to 20 percent.

It is beneficial for much of the corporate sector if the public automatically despises the government and doesn’t pressure for public interest control of it. Unlike the corporate sector, where the boards of directors (those who run the corporations) are largely determined by top management, in a undemocratic process where one share of the corporation equates to one vote in the board of directors election, there is a built-in democratic process in the government. This built-in process of one person (rather than one share) and one vote may currently be quite dysfunctional, but it is a mechanism of democratic values nonetheless, and one of the things to be strengthened for an improved society.

About every year at least, the Bulletin of Atomic Scientists meets to discuss the most significant threats to human societies, and if necessary they adjust their famous Doomsday Clock. The Doomsday Clock measures the probability of major catastrophe by the minute hand’s closeness to midnight, and it is now 2 minutes to midnight, the closest it has ever been since 1953, when America and Russia detonated thermonuclear weapons. In 2019, the Bulletin of Atomic Scientists added a third major problem to climate change and the potential of nuclear war — the breakdown of and threats to democracy. This is significant because lively and functioning democracy offers perhaps the only way to solve many of the world’s most serious problems.

Activism that is deservedly popular (and therefore democracy-based, or majority supported) is very often how things change for the better, from worker’s rights to new government programs and movements producing a beneficial change in public consciousness. Instead of only examining problems, it’s necessary to remember that to achieve progress.

Using Chronoprinting to Cheaply Detect Food and Drug Impurities

The world has long needed this valuable sort of development to safeguard people’s health.

If we could tell authentic from counterfeit or adulterated drugs and foods just by looking at them, we could save money and lives every year, especially in the developing world, where the problem is worst. Unfortunately, the technologies that can detect what a sample is made of are expensive, energy-intensive, and largely unavailable in regions where they are needed most.

This may change with a simple new technique developed by engineers from the University of California, Riverside that can detect fake drugs from a video taken as the sample undergoes a disturbance.

If you’ve ever used online photo tools, you’ve probably seen how these tools use image analysis algorithms to categorize your photos. By distinguishing the different people in your photos, these algorithms make it easy to find all the photos of your daughter or your dad. Now, in the journal ACS Central Science, researchers report they have used these algorithms to solve a very different problem: identifying fake medicines and other potentially dangerous products.

Called “chronoprinting,” the technology requires only a few relatively inexpensive pieces of equipment and free software to accurately distinguish pure from inferior food and medicines.

The World Health Organization says that about 10 percent of all medicines in low- and middle-income countries are counterfeit, and food fraud is a global problem that costs consumers and industry billions of dollars per year. Fraudulent food and drugs waste money and jeopardize the health and lives of their consumers. But detecting fakes and frauds requires expensive equipment and highly trained experts.

William Grover, an assistant professor of bioengineering in UC Riverside’s Marlan and Rosemary Bourns College of Engineering, and Brittney McKenzie, a doctoral student in Grover’s lab, wondered if it would be possible to distinguish authentic from adulterated drugs and food by observing how they behave when disturbed by temperature changes or other causes. Two substances with identical compositions should respond the same way to a disturbance, and if two substances appear identical but respond differently, their composition must be different, they reasoned.

McKenzie designed a set of experiments to test this idea. She loaded samples of pure olive oil, one of the world’s most commonly adulterated foods, and cough syrup, which is often diluted or counterfeited in the developing world, into tiny channels on a microfluidic chip, and chilled it quickly in liquid nitrogen. A USB microscope camera filmed the samples reacting to the temperature change.

McKenzie and Grover wrote software that converts the video to a bitmap image. Because the image showed how the sample changed over time, the researchers called it a “chronoprint.”

The team then used image analysis algorithms to compare different chronoprints from the same substance. They found that each pure substance had a reliable chronoprint over multiple tests.

Next, they repeated the experiment with samples of olive oil that had been diluted with other oils and cough syrup diluted with water. The adulterated samples produced chronoprints that were different from the pure samples. The difference was so big, so obvious, and so consistent the researchers concluded that chronoprints and image analysis algorithms can reliably detect some types of food and drug fraud.

“The significant visual differences between the samples were both unexpected and exciting, and with them being consistent we knew this could be a useful way to identify a wide range of samples,” McKenzie said.

Grover said their technique creates a powerful new connection between chemistry and computer science.

“By basically converting a chemical sample to an image, we can take advantage of all the different image analysis algorithms that computer scientists have developed,” he said. “And as those algorithms get better, our ability to chemically identify a sample should get better, too.”

The researchers used liquids in their experiments but note the method could also be used on solid materials dissolved in water, and other types of disturbance, such as heat or a centrifuge, could be used for substances that don’t react well to freezing. The technique is easy to learn, making highly trained experts unnecessary. Chronoprinting requires hobbyist-grade equipment and software downloadable for free from Grover’s lab website, putting it well within reach of government agencies and labs with limited resources.

Video on how this chronoprinting works: https://youtu.be/qbyE68qD2Zo

Drug Price Gouging in Generics

General info on prescription drugs and generic drug price gouging.

Martin Shkreli managed to make himself a household name a few years back. His claim to fame stemmed from the decision by Turing Pharmaceuticals, a company he founded and controlled, to acquire the rights to produce Daraprim. He then raised the price of the drug by 5,000 percent.

This was very bad news for the people who were dependent on the drug. Daraprim is an anti-parasitic drug that is often taken by people with AIDS to keep them from getting opportunistic infections. People with AIDS who are being successfully treated with Daraprim are not going to want to experiment with alternatives.

Daraprim was already a 60-year-old drug at the time Turing acquired it and had long been available as a generic. This meant that other manufacturers could in principle come into the market and compete with Turing’s inflated price.

Shkreli made the bet that no other drug company would take advantage of this opportunity, because even for a generic drug, there are still substantial costs for entry. Since the market for Daraprim was small, a new entrant would be unlikely to recover these costs if Turing pushed the price back down somewhere near its original level. While Daraprim was his biggest “success,” Shkreli was trying this strategy with a number of other drugs before the Justice Department put him out of business with unrelated charges of securities fraud.

Shkreli’s days of price gouging in the generic drug world may be over, but he established a model that other ambitious entrepreneurs are likely to follow. Close to 40 percent of generic drugs have only a single manufacturer. This is partly a result of the failure of anti-trust policy to stem a wave of mergers in the industry. It is also a result of the fact that many drugs simply have very limited markets where it is difficult to support multiple producers.

Most generic producers have not tried to follow the Shkreli model and jack up prices of drugs that people need for their health or even their lives, but some have. The soaring price of insulin is one important example, EpiPen, the asthma injector, is another. Both involve well-known treatments that have long been used, but the limited number of suppliers has allowed for huge price increases in recent years.

This is the context for the public drug-manufacturing corporation being proposed in a bill by Senator Elizabeth Warren and Representative Jan Schakowsky. The idea is that the federal government should create manufacturing capacity (which could be privately licensed) that would allow it to quickly enter a market to compete with the next Martin Shkreli.

If a company tries to jack up its prices by an extraordinary amount, it would find itself soon competing with a government manufacturer that is selling the same drug for the cost of production, plus a normal profit. This is a great strategy, since simply the existence of this capacity should be sufficient to discourage the next Shkreli.

There will be little money in jacking up the price of a drug by 5,000 percent if it quickly results in the disappearance of their market. This should encourage the generic industry to keep its prices in line.

It is important to note a key difference between the generic industry and brand industry. The brand pharmaceutical companies, like Pfizer and Merck, could argue that they need high prices to pay for research. These companies hugely exaggerate their research costs and downplay the extent to which high profits just mean more money for shareholders, but they actually do research.

By contrast, the generic industry is not researching new drugs. They are manufacturing drugs that have been developed by others. In this sense they can be thought of like a company that manufacturers paper plates or shovels. They need a normal profit to stay in business, nothing more.

For this reason, the Warren-Schakowsky proposal is very much the right type of remedy for excessive prices in the generic drug industry. At the same time, we have to recognize that generic drugs are the smaller part of the problem with high drug prices.

Although generics account for almost 90 percent of prescriptions, they account for only a bit more than a quarter of spending on prescription drugs. The story of drugs costing tens or hundreds of thousands of dollars a year is almost entirely a story of brand drugs with high prices as a result of patent monopolies or related protections.

This will require a larger fix, likely along the same lines, with the government paying for research and allowing new drugs to be sold as generics. But the Warren-Schakowsky bill is a huge first step in bringing drug costs down and ensuring that people will not find themselves suddenly at the mercy of the next Martin Shkreli.

Hundreds of Supplements Tainted With Hidden Drugs

This is why people should use caution when taking supplements, and it also shows the risk of inadequate corporate oversight. Unlike pharmaceutical drugs, the American supplement industry is barely regulated at all.

The labels promise miracles: Fast Weight Loss! Eliminates Hunger! Burns Calories!

Now new research highlights how hundreds of brands of dietary supplements deliver so much kick from a modest blend of vitamins and herbs. The answer is many labels leave out one important ingredient: a hidden payload of pharmaceutical drugs and experimental chemicals.

A new analysis of 10 years of FDA records reveals that from 2007 to 2016, almost 750 dietary supplements were found to be contaminated with secret doses of totally unregulated drugs, including prescription medicines, banned and unapproved chemicals, and designer steroids.

Over 20 percent of these offending products contained more than one unapproved drug ingredient, and numerous contained a cocktail of clandestine chemicals – in two cases, as many as six unlisted ingredients.

For a US$35 billion industry patronised by about half of American adults, it’s possible this data could be just the tip of the iceberg, too.

“The drug ingredients in these dietary supplements have the potential to cause serious adverse health effects owing to accidental misuse, overuse, or interaction with other medications, underlying health conditions, or other pharmaceuticals within the supplement,” researchers from the California Department of Food and Agriculture, Sacramento, explain in their paper.

Given that supplement use is associated with some 23, 000 ER visits and 2,000 hospitalisations in the US each year, it’s clear we’re looking at a big problem here, but what’s even more shocking than the brazen selling of these illicit additives is how tame and toothless the FDA’s official actions were.

Of 746 products identified as adulterated by the FDA, just 360 (48 percent) were subsequently recalled, leaving more than half of the contaminated supplements available for sale.

“The agency’s failure to aggressively use all available tools to remove pharmaceutically adulterated supplements from commerce leaves consumers’ health at risk,” writes general internist Pieter Cohen from Harvard Medical School in a commentary on the new research.

Many of the tainted supplements analysed in the study contained sildenafil (the active ingredient of Viagra) to boost their powers of sexual enhancement. Another erectile dysfunction drug, tadalafil, was also common.

Other chemicals included hidden antidepressants, a withdrawn weight loss drug called sibutramine, and undeclared anabolic steroids or steroid-like substances.

It’s been argued however that since almost 75 percent of the offending supplements were sold online or through international mail order, they don’t represent the ‘mainstream’ of the supplements industry.

“These come from dark corners of the internet,” president of the Natural Products Association, Daniel Fabricant, told the San Francisco Chronicle.

“They’re not what you get at your health food store.”

Still, given that none of these products are actually subjected to the same stringent tests reserved for pharmaceutical drugs, it’s possible any supplement could contain anything – which is why Cohen advises choosing products that only contain a single ingredient and avoiding products that purport to offer spurious, medical-sounding benefits.

Why? Because as this research shows, many supplements turn out to be medicine after all – only it’s an unknown drug, potentially a banned one, and there’s no way of measuring your dose.

“If the company is saying it works like Viagra or you’re going to gain muscle like you’re on steroids – that’s not a supplement. That’s a drug,” Fabricant says.

“Dietary supplements are meant to maintain health, not to take 30 minutes before sex.”

The findings are reported in JAMA Network Open.

Good Immunotherapy is Amazing at Treating Cancer — And It’s Unnecessarily Expensive

Drugs are cheap to produce — it’s things like unjust government-granted patent monopolies that allow pharmaceutical companies to charge exorbitant prices that make drugs expensive.

To quote economist Dean Baker’s latest October 2018 paper:

“Many items that sell at high prices as a result of patent or copyright protection would be free or nearly free in the absence of these government granted monopolies. Perhaps the most notable example is prescription drugs where we will spend over $420 billion in 2018 in the United States for drugs that would almost certainly cost less than $105 billion in a free market. The difference is $315 billion annually or 1.6 percent of GDP. If we add in software, medical equipment, pesticides, fertilizer, and other areas where these protections account for a large percentage of the cost, the gap between protected prices and free market prices likely approaches $1 trillion annually, a sum that is more than 60 percent of after-tax corporate profits.”

On to the article though.

Last week, researchers James Allison and Tasuku Honjo were awarded this year’s Nobel Prize in medicine for their work on cancer immunotherapies, heralded by the Nobel committee as “seminal discoveries” that “constitute a landmark in our fight against cancer.”

Immunotherapies like those developed on the basis of Allison and Honjo’s work are indeed an important step towards a whole new way to treat cancer, as well as a host of other chronic diseases. However, this Nobel award should remind us that these innovative therapies are out of reach for so many patients in the United States due to the exorbitant prices drug companies charge for them.

Just weeks before the Nobel announcement, oncologist Ezekiel Emmanuel wrote in a Wall Street Journal essay, “We Can’t Afford the Drugs That Could Cure Cancer,” that “a cure for cancer has become possible, even probable” with immunotherapies, but that our health system cannot afford their price tag. Just after the Nobel announcement, Vox reporter Julia Belluz reminded us that “the average cost of cancer drugs today is four times the median household income” (emphasis added).

Immunotherapies constitute a part of the class of drugs called biologics (as opposed to chemical pharmaceuticals) that have shown very promising results in treating many previously intractable conditions, such as multiple sclerosis, asthma, chronic pain, and Crohn’s disease, due to their ability to more precisely target individual diseased cells. Therefore it’s no surprise that currently most of the top 10 best-selling drugs worldwide are biologics.

[…]

If biologics really are the future of medicine, we must change the way prescription drugs are priced in the United States, or millions of patients will be left behind. One way to do that is to invest in public pharmaceuticals that can assure an adequate supply of and equitable access to essential medications.