Tag Archives: Studies

PRESCRIPTION DRUGS: ‘WHY THEY REMAIN HIGH-PRICED’

There may be few issues that unite Americans ahead of the 2020 election as do their concerns about the cost of prescription drugs.

A clear majority — 75% — of respondents to a July survey said the cost of prescription medicines would be among the factors likely to influence their votes this year, according to a report from Gallup and the nonprofit West Health. Gallup reported on results from 1,007 interviews conducted with adults between July 1 and July 24.

1. What are the 2020 presidential candidates saying they will do to lower drug prices?

Both President Donald Trump, a Republican, and former Vice President Joe Biden, a Democrat, have highlighted insulin costs in their discussions of the need to lower drug prices.

In a January interview with the New York Times editorial board, Biden noted the widespread discontent among Americans about sticker shock often experienced at pharmacies. He spoke of a need for the federal government to act to make medicines more affordable.

“This is a place where I find, whether you’re Republican or Democrat, you think you’re getting screwed on drug prices. And you are, in terms of everything from insulin to inhalers and a whole range of other things,” Biden said. “So, again, can I guarantee that it gets done? No, but I can tell you what, if anybody can get it done, I can, and I think there’s a consensus for it.”

2. Why doesn’t Medicare, the biggest U.S. purchaser of drugs, directly negotiate on drug prices?

Congress has taken different approaches in designing the terms under which the two largest federal health programs, Medicaid and Medicare, buy drugs.

Medicaid is a program run by states with federal contributions and oversight. It covers people with low incomes and disabilities. Almost 67 million people were enrolled in Medicaid as of May 2020, including about 29 million children. In 1990 Congress decided that drugmakers who want to have their products covered by Medicaid must give rebates to the government. The initial rebate is equal to 23.1% of the average manufacturer price (AMP) for most drugs, or the AMP minus the best price provided to most other private-sector payers, whichever is greater. An additional rebate kicks in when prices rise faster than general inflation.

3. What’s the deal with rebates and discounts?

There’s widespread frustration among lawmakers and policy analysts about the lack of clarity about the role of middlemen in the supply chain for medicines. Known as pharmacy benefit managers (PBMs), these businesses describe the aim of their business as making drugs more affordable for consumers. Insurers like Cigna and UnitedHealth operate some of the nation’s largest PBMs, as does pharmacy giant CVS Health, which also owns insurer Aetna.

“They will tell you their mission is to lower drug costs,” said Rep. Earl L. “Buddy” Carter, a Georgia Republican, a pharmacist and a critic of PBMs, in a speech on the House floor last year. “My question to you would be: How is that working out?”

4. What is the “distinctly American” phenomenon of specialty drugs?

Kesselheim also has written on what he terms “Specialty Drugs — A Distinctly American Phenomenon.” That’s the title of a 2020 paper in the New England Journal of Medicine Kesselheim authored with Huseyin Naci, an associate professor of health policy at the London School of Economics.

In this Perspective article, Kesselheim and Naci look at how the “specialty” designation morphed from its origin in the 1970s. It then referred to a need for extra steps for preparation and delivery of new injectable and infusion products.

5. How much does it cost to bring a new drug to market anyway? 

The median cost for a medicine developed in recent years was $985 million, according to a study published in JAMA in March 2020, “Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018.”

“Rising drug prices have attracted public debate in the United States and abroad on fairness of drug pricing and revenues,” write the study’s authors: Olivier J. Wouters of the London School of Economics; Martin McKee of the London School of Hygiene and Tropical Medicine; and Jeroen Luyten of Leuven Institute for Healthcare Policy, KU Leuven, Belgium. “Central to this debate is the scale of research and development investment by companies that is required to bring new medicines to market.”

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COVID-19 STUDIES: 77% OF HOSPITALIZED PATIENTS ARE OVERWEIGHT OR OBESE

SEPTEMBER 11, 2020

The Journal Science recently reported on nearly 77,000 patients hospitalized with Covid 19.  29% were overweight and 48% were Obese. A total of 77% of admissions for Covid were overweight or worse.

Overweight was defined as BMI of 25-29.9 Kg. per Square Meter, and Obese was defined as BMI of 30 or greater. Another way of stating the data is giving the rate of Hospital admissions per 10,000 People.

  • Normal Weight, BMI 18.5-25 kg. Per square Meter—12%
  • Overweight, BMI 25-29.9 per square a Meter———-19%
  • Obese, BMI 30-34.9 per square Meter——————-23%
  • Severe Obesity, more than 35 per square meter——-42%

BMI calculators are everywhere to be found on the internet. Put in your weight and height, and find your BMI displayed.

These are striking figures, the more so because of the LARGE SAMPLE, and the LINEAR Relationship; the greater the overweight, the greater the hospitalization rate.

Every way you look at it, obesity is hazardous. More hip and knee replacements, harder to exercise, find comfortable seats, more difficult to do surgery, more diabetes, heart attacks, stroke, Hypertension, Sleep apnea, worse immunity, and now, confirming previous suspicions, clearly higher risk of being hospitalized (and dying) with Covid.

I realize that nobody chooses to be Obese; in addition to the health problems,  overweight people are Subjected to discrimination.

Obesity is notoriously hard to treat; one of the few, seldom mentioned medical truths is that Diets fail long term. Starting and maintaining a diet takes Herculean Will Power, which is in short supply in our overindulgent, overadvertised, and overfed society.

If I were morbidly Obese, I might opt for Bariatric Surgery, and try my best to hold the short term weight loss, since even with surgery the pounds tend to creep back on over time.

The best way to treat Obesity is to treat it as the Plague it is. CHILDHOOD OBESITY should be treated aggressively. Keep the Obese Child from becoming an obese adult, and maybe carry yourself along with the Family.

Better yet, Good SLEEP, DIET, and EXERCISE come as an interactive mutually reinforcing package deal. Prevention always beats treatment.

My article on ABDOMINAL FAT is suggested reading, and there is a link to the Infographic which Displays the above date in graphic form.

—Dr. C.

Read Science article online

BRAIN RESEARCH: 40% OF DEMENTIA CASES PREVENTED WITH LIFESTYLE CHANGES

“We are learning that tactics to avoid dementia begin early and continue throughout life, so it’s never too early or too late to take action,” says commission member and AAIC presenter Lon Schneider, MD, co-director of the USC Alzheimer Disease Research Center‘s clinical core and professor of psychiatry and the behavioral sciences and neurology at the Keck School of Medicine of USC.

LOS ANGELES — Modifying 12 risk factors over a lifetime could delay or prevent 40% of dementia cases, according to an updated report by the Lancet Commission on dementia prevention, intervention and care presented at the Alzheimer’s Association International Conference (AAIC 2020).

Twenty-eight world-leading dementia experts added three new risk factors in the new report — excessive alcohol intake and head injury in mid-life and air pollution in later life. These are in addition to nine factors previously identified by the commission in 2017: less education early in life; mid-life hearing loss, hypertension and obesity; and smoking, depression, social isolation, physical inactivity and diabetes later in life (65 and up).

Schneider and commission members recommend that policymakers and individuals adopt the following interventions:

  • Aim to maintain systolic blood pressure of 130 mm Hg or less from the age of 40.
  • Encourage use of hearing aids for hearing loss and reduce hearing loss by protecting ears from high noise levels.
  • Reduce exposure to air pollution and second-hand tobacco smoke.
  • Prevent head injury (particularly by targeting high-risk occupations).
  • Limit alcohol intake to no more than 21 units per week (one unit of alcohol equals 10 ml or 8 g pure alcohol).
  • Stop smoking and support others to stop smoking.
  • Provide all children with primary and secondary education.
  • Lead an active life into mid-life and possibly later life.
  • Reduce obesity and the linked condition of diabetes.

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STUDIES: 4- AND 6-HOUR TIME-RESTRICTED EATING (TRE) DIETS, NO FOOD LIMITS RESULT IN WEIGHT LOSS

“The findings of this study are promising and reinforce what we’ve seen in other studies — fasting diets are a viable option for people who want to lose weight, especially for people who do not want to count calories or find other diets to be fatiguing,” Varady said. 

…participants in both daily fasting groups reduced calorie intake by about 550 calories each day simply by adhering to the schedule and lost about 3% of their body weight. The researchers also found that insulin resistance and oxidative stress levels were reduced among participants in the study groups when compared with the control group.

4- And 6-Hour Time Restricted Eating TRE Diets

Two daily fasting diets, also known as time-restricted feeding diets, are effective for weight loss, according to a new study published by researchers from the University of Illinois at Chicago.

The study reported results from a clinical trial that compared a 4-hour time-restricted feeding diet and a 6-hour time-restricted feeding diet to a control group.

“This is the first human clinical trial to compare the effects of two popular forms of time-restricted feeding on body weight and cardiometabolic risk factors,” said Krista Varady, professor of nutrition at the UIC College of Applied Health Sciences and corresponding author of the story.

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COMMENTARY

Time-restricted eating brought my weight down from 142 pounds to 136, which is close to what was found on the study; not much, but every pound counts. The improved insulin resistance was reassuring but I am surprised they didn’t find any effects on the HDL, LDL and triglycerides.

The most detailed study on time restricted eating and fasting in general was in the New England Journal of Medicine in December 26, 2019. That excellent article went into all kinds of metabolic pathways that are benefited by fasting.

Good sleep,  diet and exercise can be very helpful.

–DR. C

NEJM Article

COGNITION & BRAIN STUDIES: APATHY, NOT DEPRESSION, ASSOCIATED WITH DEMENTIA

jnnp-2020-July-91-7-677-F1.medium

We tested the hypothesis that apathy, but not depression, is associated with dementia in patients with SVD. We found that higher baseline apathy, as well as increasing apathy over time, were associated with an increased dementia risk. In contrast, neither baseline depression or change in depression was associated with dementia. The relationship between apathy and dementia remained after controlling for other well-established risk factors including age, education and cognition. Finally, adding apathy to models predicting dementia improved model fit. These results suggest that apathy may be a prodromal symptom of dementia in patients with SVD.

Cerebral small vessel disease (SVD) is the leading vascular cause of dementia and plays a major role in cognitive decline and mortality.1 2 SVD affects the small vessels of the brain, leading to damage in the subcortical grey and white matter.1 The resulting clinical presentation includes cognitive and neuropsychiatric symptoms.1

Apathy is a reduction in goal-directed behaviour, which is a common neuropsychiatric symptom in SVD.3 Importantly, apathy is dissociable from depression,3 4 another symptom in SVD for which low mood is a predominant manifestation.5 Although there is some symptomatic overlap between the two,6 research using diffusion imaging reported that apathy, but not depression, was associated with white matter network damage in SVD.3 Many of the white matter pathways underlying apathy overlap with those related to cognitive impairment, and accordingly apathy, rather than depression, has been associated with cognitive deficits in SVD.7 These results suggest that apathy and cognitive impairment are symptomatic of prodromal dementia in SVD.

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COVID-19: “SUPERSPREADING EVENTS” – HOW THEY LEAD TO 80% OF INFECTED PEOPLE

From Scientific American (June 23, 2020):

Scientific American

In fact, research on actual cases, as well as models of the pandemic, indicate that between 10 and 20 percent of infected people are responsible for 80 percent of the coronavirus’s spread.

Researchers have identified several factors that make it easier for superspreading to happen. Some of them are environmental.

  • Poorly ventilated indoor areas seem especially conducive to the virus’s spread – A preliminary analysis of 110 COVID-19 cases in Japan found that the odds of transmitting the pathogen in a closed environment was more than 18 times greater than in an open-air space.
  • Places where large numbers of people congregate – As a group’s size increases, so does the risk of transmitting the virus to a wider cluster. A large group size also increases the chance that someone present will be infectious.
  • The longer a group stays in contact, the greater the likelihood that the virus will spread among them – The benchmark used for risk assessment in her contact-tracing work is 10 minutes of contact with an infectious person, though the CDC uses 15 minutes as a guideline.
  • Some activities seem to make it easier to spread respiratory gunk – Speech emits more particles than normal breathing. And emissions also increase as people speak louder. Singing emits even more particles, which may partially explain the superspreader event at the Washington State choir practice. Breathing hard during exercise might also help the spread of COVID-19.

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DIET STUDIES: HIGH-SUGAR DIETS SUPPRESS DOPAMINE, LEADING TO OVEREATING

From Phys.org/Univ. of Michigan (June 9, 2020):

High-Sugar Diet Dampens Release of Dopamine Causing Overeating - Univ of Michigan - Credit Christina May and Monica Dus

“On a high-sugar diet, we find that the fruit flies’ dopaminergic neurons are less active, because the high sugar intake decreases the intensity of the sweetness signal that comes from the mouth,” Dus said. “Animals use this feedback from dopamine to make predictions about how rewarding or filling a food will be. In the high-sugar diet flies, this process is broken—they get less dopamine neuron activation and so end up eating more than they need, which over time makes them gain weight.”

It is well known that consuming food and drink high in sugar is not great for us, but scientists are continuing to unravel the intricacies of how the sweet stuff drives negative health outcomes. The latest finding comes from researchers at the University of Michigan, who through studies in fruit flies have found that excess amounts of sugar can shut down crucial neural circuits linked to regulating satiety, possibly leading to overeating in humans.

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COMMENTARY

SUGAR IS A POISON.

A novel illustration of sugars’ lethality was the Georgia sugar refinery explosion in 2008, which killed 14 people. Finely ground sugar is flammable.

Sugar appeared early in civilization, but it was expensive, sparing all but the wealthy of its’ depredations, mainly tooth decay.  Only with the post WWII expansion of wealth was it consumed excessively to produce the diseases of overeating. The developed world now consumes over 70 pounds of sugar per person, amounting to over 250 CALORIES PER DAY!

This  article shows how SUGAR acts like a DRUG In its INTERFERENCE with the DOPAMINERGIC Reward system. The neurons send less signal, so you need MORE SUGAR to satisfy.

The metabolic systems through which overeating and sugar causes the OBESITY, DIABETES, VASCULAR DISEASE and Early DEMENTIA are convoluted.The best detailed explication is in the NEJM article in intermittent fasting, a healthful practice that is the polar opposite of overeating.

Two very important metabolic mechanisms are discussed, the mTOR system and the Sirtuin system. These systems are important for NUTRIENT SENSING and repair, and conserved in all animals. They worked just fine in our early ancestors.

It seems that primitive man was not blessed (or is it cursed) with easy overabundance or food, and actually spent hours or days in Hunger. When times were good, his body put on muscle, and stored fat against the hard times to come. This is called ANABOLISM. When times were bad, his body went into repair mode, and used the fat for energy. This is called CATABOLISM.

Anabolism has evolved expressly for Young Animals, where extra food is welcome for Growth. After the growing and Reproductive years, our Bodies’ evolutionary “warrant” expires, since the genes it carries have already been spread. Our older bodies are left to deal with machinery more suited to an earlier vibrancy. Our metabolism didn’t evolve to deal with the calories we shove into our aging Bodies. Many mechanisms beneficial in the young prove harmful later on. This divergence has been called “ antagonistic pleiotropy”.

Whatever the explanation, the observation remains: if adults eat more than they can use, they gain weight. With insufficient exercise, this weight is fat. With excessive fat, the joints, blood vessels, liver, heart and brain suffer,  and lifespan is shortened.

RETHINK YOUR LIFESTYLE AS SOON AS POSSIBLE. AVOIDING SUGAR, and ALL THINGS CONTAINING SUGAR is as good a place as any to start. You will be rewarded by being able to fully taste and enjoy the natural sweetness of many REAL FOODS, and afforded a longer life to partake in this pleasure.

—Dr. C.

STUDIES: CHRONIC SLEEP DEPRIVATION CAUSES TOXIC CHANGES IN GUT HEALTH, INCREASED EARLY MORTALITY

From Harvard Medical School (June 4, 2020):

“We took an unbiased approach and searched throughout the body for indicators of damage from sleep deprivation. We were surprised to find it was the gut that plays a key role in causing death,” said senior study author Dragana Rogulja, assistant professor of neurobiology in the Blavatnik Institute at HMS.

The first signs of insufficient sleep are universally familiar. There’s tiredness and fatigue, difficulty concentrating, perhaps irritability or even tired giggles. Far fewer people have experienced the effects of prolonged sleep deprivation, including disorientation, paranoia, and hallucinations.

Total, prolonged sleep deprivation, however, can be fatal. While it has been reported in humans only anecdotally, a widely cited study in rats conducted by Chicago-based researchers in 1989 showed that a total lack of sleep inevitably leads to death. Yet, despite decades of study, a central question has remained unsolved: Why do animals die when they don’t sleep?

Now, Harvard Medical School (HMS) neuroscientists have identified an unexpected, causal link between sleep deprivation and premature death.

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STUDY: “INTENSIVE DIET AND EXERCISE” REVERSES TYPE 2 DIABETES IN 61% OF PATIENTS

From The Lancet Diabetes & Endocrinology (June 2020):

Our findings show that the intensive lifestyle intervention led to significant weight loss at 12 months, and was associated with diabetes remission in over 60% of participants and normoglycaemia in over 30% of participants. The provision of this lifestyle intervention could allow a large proportion of young individuals with early diabetes to achieve improvements in key cardiometabolic outcomes, with potential long-term benefits for health and wellbeing.

The Lancet Diabetes & Endocrinology

Type 2 diabetes is affecting people at an increasingly younger age, particularly in the Middle East and in north Africa. We aimed to assess whether an intensive lifestyle intervention would lead to significant weight loss and improved glycaemia in young individuals with early diabetes..Between July 16, 2017, and Sept 30, 2018, we enrolled and randomly assigned 158 participants (n=79 in each group) to the study. 147 participants (70 in the intervention group and 77 in the control group) were included in the final intention-to-treat analysis population. Between baseline and 12 months, the mean bodyweight of participants in the intervention group reduced by 11·98 kg (95% CI 9·72 to 14·23) compared with 3·98 kg (2·78 to 5·18) in the control group (adjusted mean difference −6·08 kg [95% CI −8·37 to −3·79], p<0·0001). In the intervention group, 21% of participants achieved more than 15% weight loss between baseline and 12 months compared with 1% of participants in the control group (p<0·0001). Diabetes remission occurred in 61% of participants in the intervention group compared with 12% of those in the control group (odds ratio [OR] 12·03 [95% CI 5·17 to 28·03], p<0·0001). 33% of participants in the intervention group had normoglycaemia compared with 4% of participants in the control group (OR 12·07 [3·43 to 42·45], p<0·0001)

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