The Medical News Report

#97

February, 2020

Samuel J LaMonte, M.D., FACS

www.themedicalnewsreport.com

Dear Readers,

This marks 7 full years of my reports. It is hard to believe I just completed the 97th monthly report. As always, it is my pleasure to provide you with the latest information in medicine and healthcare (plus subject index), commercial free, and with no subscription cost to the reader. Thank you for reading these advances in medicine and healthcare. Stay healthy and well my friends!

Also this is heart month, so get a check up!

Dr. Sam

Happy Valentine’s Day

Subjects:

1. Plant based diets and others trending (Fasting, Mediterranean, DASH, At+kins,

 Keto, Alkaline, Paleo, etc.); Body cleansing and Detox techniques; Activated

 charcoal; Top 10 diets googled in 2019

2. Medical Updates

    A. Supplements for brain health; value of glucosamine; quack methods

    B. Stem cell treatment—unproven in many cases

    C. How many steps (walking) are necessary to reduce mortality

    D. The effect of menstrual periods on productivity in women

3. Minimally invasive Robotic Knee Replacement Surgery—new technique

4. Cancer death rates taking a dive; Treating chronic pain in cancer survivors—not easy!

5. Ongoing Drug cost issues

     1- Attempts to reduce drug costs ongoing,

      2- Medicare Part D (prescription plans) changes in 2020

      3- Need for better regulation of dietary supplements

      4- Drug importation from Canada

IMPORTANT REMINDER!!!! PLEASE READ!!!

  I remind you that any medical information provided in these reports is just that…information only!! Not medical advice!! I am not your doctor, and decisions about your health require consultation with your trusted personal physicians and consultants.

  The information I provide you is to empower you with knowledge, and I have repeatedly asked you to be the team leader for your OWN healthcare concerns.  You should never act on anything you read in these reports. I have encouraged you to seek the advice of your physicians regarding health issues. Feel free to share this information with family and friends, but remind them about this being informational only. You must be proactive in our current medical environment.

  Don’t settle for a visit to your doctor without them giving you complete information about your illness, the options for treatment, care instructions, possible side effects to look for, and plans for follow up. Be sure the prescriptions you take are accurate (pharmacies make mistakes) and always take your meds as prescribed. The more you know, the better your care will be, because your doctor will sense you are informed and expect more out of them. Always write down your questions before going for a visit.

  Thanks!! Dr. Sam

Donate to the American Heart Association

www.heart.org

     This is Heart Month!!!

1. PLANT-BASED DIET and trending diets including the fasting diets; TOP 10 DIETS in 2019; BODY CLEANSING; DETOX techniques; Activated charcoal

  At the first of every year, New Years resolutions abound. If a person is serious about improving health, losing weight, and lowering heart, diabetic, and cancer risks, there is firm evidence that some of these diets are for real and can improve serious health issues. But fad diets are still to be questioned. There are still a lot of diets that still need more research to prove their value.

  The question is…can one stick to it for life? Give it a try and see if it works. The bottom line….any nutritional diet recommendations still include a diet rich in vegetables and fruit. After that, there is a “Duke’s mixture” of variations with omissions and additives that I have provided the reader in this report.  

A. Body Cleansing and Detoxification methods

  Detox diets usually start with a period of fasting followed by ingestion of raw vegetables and fruits with juicing, and water. Some add herbs to the juicing procedure along with enemas to remove colonic contents, which does nothing but dehydrate a person and deplete the body of electrolytes, but will give a person a temporary weight loss from the dehydration.

  Many claim they feel much better after these detox diets, and it may be that eliminating processed foods, solid fats, and sugars is the reason. The word detox may sound great, but that process is already nicely performed by the liver and kidneys, and there is no evidence that diets or fasting removes toxins from the body.

  However, there is evidence that fasting once a week and eating more plant based diets are valuable and can lead to weight loss, and if followed over many years, eventual improvement in cardiovascular diseases, hypertension, insulin resistance, and even reduce the risk of some cancers. Mayo Clinic

B. Plant-based diets

There are many studies that have endorsed diets that consist primarily of vegetables and fruits for their obvious health value. Contrary to common knowledge, plants provide all the protein a body needs for most people, although most people get more protein from meat, eggs, and fish.

  Giving up all meats, fish, and fowl, oils, and other products requires dedication to this diet, but the results, if maintained over a lifetime, are clearly valuable to those in need of management of many health issues. Most cannot maintain such a diet, so compromise can still be valuable in reducing bad foods and increasing the good.

As reported on a well known nutritional website, Forks over Knives, they report 7

benefits from giving up meat:

1. Reduce inflammation in the body from animal protein.

2. Reduce cholesterol by dropping saturated fat that is contained in meats, poutry, and cheeses.

3. Rebuild the microbiome. This is the bacteria primarily in the gut. They play a major role in digestion, health overall, including major contributions to the immune system. Additionally, ingestion of choline and carnitine from meats and egg yolks, can create byproducts (called TMAO*) that occur from a reaction to stomach bacteria that can aggravate heart disease. Plant based diets do not produce TMAO. *trimethlyamine-N-oxide

4. Our diet can influence how certain genes can be turned on and off. Although I can’t verify, this website states that a plant-based diet can influence certain cancer genes by improving cellular repair of DNA. There is certainly ongoing research regarding the influence of nutrition on genes.

5. Reduce developing type 2 diabetes. Eating meat and othe animal products tend to create more weight gain than plant-based diets, which increases the risk of diabetes. There are other less research verified reasons, but through observational research (not the best), those on a plant-based diet have much less chance of contracting diabetes.

6. Eating meat brings more protein into the body than is needed.

  A recent study from 7 different countries (I reported it on the discussion of eating red meat in the December report) did not see negative consequences from eating a reasonable amount of protein from meat and processed meats, and did not recommend stopping but recommended moderation. There has been major blowback in the U.S. from the medical community, but the study is solid.

  This Fork over Spoons website stated than excess protein is stored as fat and encourages weight gain and leads to various health consequences. This website did not provide any research articles to back up this claim.

7. Improves greenhouse gases with lower consumption of animal products. This is a potential long term benefit.

www.forksoverknives.com/print/print.php?id=27502

The basic principles of a plant-based diet is:

emphasizes whole foods minimally processed, limits or avoids animal based products, diet mostly made up of vegetable, fruits, legumes, whole grains, seeds, and nuts, excludes refined foods (sugars, flour, and processed oils), with focus on organic and locally grown plant based foods.

Difference from vegan diet and plant based diets

  Although primarily eating a plant based diet, many vegans eat some fish, eggs, and some dairy and lean meats.

  Eliminating saturated fats has made sense since medicine discovered the problem, however, polyunsaturated fats have shown medical value. Some vegans and those who choose a strict plant-based diet have taken it to another level if they totally eliminate fats, oils, and any form of meat, fish, or dairy, and therefore miss out on the good fats, although fruits like avocados, nuts, etc. can replace those lost with their natural oils. So in a sense, they are not giving up all oils, only those processed.  

  JAMA, August 26, 2019, compared animal based versus plant based proteins in a diet as it applies to its effect on mortality rates. Although the animal based protein sources did not have a negative effect on all-cause mortality, a plant- based protein diet did reduce all-cause mortality, cardiovascular and cancer deaths. It should be noted that other studies have shown an increase in cardiovascular mortality with an animal-based protein diet.

   Most highly rated diets support a diet high in vegetables and fruits. Replacing processed animal protein and fat (bacon, sausage, ham, lunch meat) with a plant-based protein diet reduced mortality for cardiovascular and cancer even more. High intake of plant based proteins compared to low intake revealed a 30% decrease in risk of heart attacks. 

  The reason this is important is that both the Atkins diet pushes animal fats and protein and low carbs while the Keto diet (discussed later in this article) pushes fats, and limits carbs and protein, and both can cause weight loss. How did they compare with a plant based protein diet? Both work in different ways.

  The animal based protein diet is probably successful because people get full quickly and don’t need to eat as often, so weight loss occurs. However, there is a reduction of cardiovascular disease. It can reduce blood pressure, lipid levels, and glucose control. However, it has never been proven that the high animal based protein diets reduce cardiovascular deaths.

   Some of the studies are published from the Orient where the source of animal protein is different (more fish and soy) than in the West. Most of the studies comparing diets are all observational which diminishes their validity compared to a strict double blind evidence based study.

Best Results

  Intake of higher amounts of plant-based protein has been associated with a reduction of blood pressure, waist circumference (BMI), and weight. The LDL cholesterol (bad cholesterol) was lowered by plant-based proteins (nuts and grains) in addition to lower blood glucose levels and reduced insulin resistance with a lower incidence to type 2 diabetes.

Composition of plant-based diets:

  Cereals*, pulses**, vegetables, nuts, and fruits create the bulk of the plant proteins and carbohydrates.

*Cereals consist of rice, wheat, corn, barley, and maize. **Pulses are edible peas, beans, lentils, and chickpeas.

Some of the sites for plant based diets promote certain healthy fats-olive oil, avocado, coconut oil, and unsweetened coconut. Others are adamant that no processed oils be used. Milks recommended include almond, coconut, and cashew milk.

  For more information on what is approved, to be minimized, and avoided, and sample menus, search: www.healthline.com/nutrition/plant-based-diet-guide

 Summary

  Substituting plant based foods in place of meat and processed meats did reduce all-cause mortality in this study and others. Those who eat good quality meats, fish, poultry, and minimal processed meats may not reduce their cardiovascular disease risks but do not make it worse unless the total calories exceed recommended and weight gain creates the risks. Its always about the number of calories. 

  Therefore, for any person with a heavy history of cardiovascular disease and cancer (or who actively have these diseases), it should be obvious that it is time to admit an adjustment in diet is the most critical method to try and prevent these diseases in addition to exercise, adequate sleep, alcohol moderation, reduction of stress, proper preventative medications, and routine screenings.

Why won’t doctors get on the nutrition bandwagon?

  This should be on the lips of every doctor encouraging their patients to start changing their behavior to have the longest and healthiest life they possibly can. The trouble is, medical doctors mostly are not preventative minded and don’t get paid for discussions in nutrition (criminal). That means that the public must take action.

   Shifting to these restrictive diets should be gradual so that the person can find what amount of plant-based diet they can stick with. Also asking the doctor for a look at the chemistries before starting and after 3-6 months is one way to track progress plus weighing weekly.

   Remember, even cutting meat, processed foods, saturated fats, and sugary products in half to start with will reap benefits, but to expect benefits, one must stick to these healthy choices long term. Each person must find out what they can stick with over time, otherwise, the benefits will not be realized. It would be smart to discuss any of these diet changes with the doctor based on a person’s medical status.  

C. The alkaline diet

   This is a huge industry even with little proven research to support their benefit, but I report on (not to promote them). Alkaline diets and water need to be understood, and then people can discuss these issues with their doctors, if you can find one who is versed in all these diet choices.

The body cleanser proponents believe that putting foods into the body to match the body’s ph will give the body more energy by getting rid of the body’s metabolic ash, the byproduct of food metabolism and will improve health. Foods that create more acidic ash are proteins, phosphate, and sulfur products while alkaline products contain calcium, magnesium, and potassium.

  Cleansing the body with various methods, fasting, going on a water diet, you name it, may help some, but they do not hold up when compared to just sticking to a normal balanced healthy diet rich in plant based foods-vegetables, fruits, nuts, and proteins from fish and chicken, and yes, many of the best foods are alkaline.

D. Paleo Diet

The caveman diet’s main premise is there was no processed foods back in the Paleolithic Era. This diet recommends organic foods, nuts, seeds, lots of vegetables and fruits, grass fed meat, and fish. No frozen or canned foods. Eggs, avocado, sweet potato, and olives are ok. Off-limits are legumes (potatoes, beans, peanuts, pees), dairy, sugars, and highly processed foods, and whole grains. Carbs are limited to 23% of the food a person eats.

  This diet promotes the 80/20 concept. If a person sticks to this diet 80% of the time, the other 20% can be less rigid with ingestion of some grains, dairy, and a rare sweet is allowed.

Reference:

Medicine.net

E. Trending diets including the top 10 searches by google for diets

  The South Beach diet, the Mediterranean diet, etc. all basically follow common sense regimens. At the end of the day, exercise, good restful sleep, reduction of stress, weight maintenance, control of health issues, not smoking, and minimal alcohol intake will give you all the health you need!

Foods that are acidic (low ph), neutral, or alkaline (high ph):

 --Acidic foods are meats, poultry, fish, eggs, grain, dairy, and alcohol.

--Neutral foods are fats, starches, and sugars.

--Alkaline foods are fruits, legumes, nuts, and vegetables.

  To digest foods requires a very acidic environment. Stomach acid (ph of 2.5-3.5) and pancreatic enzymes digest foods. However, the body is quite efficient in keeping the body’s ph between 7.3-7.4.

  Food does not affect the body’s ph, regardless of the ph of the food. but can change the urine ph, which does not coincide with the blood ph. But proponents recommend checking the ph of the urine. They can convince themselves that they are healthier if their urine ph rises to alkaline levels. If food can’t change the body’s ph, then it is just not valuable for health on the basis of changing the ph alone.

  However, if one chooses many of the alkaline foods, which are recommended by any nutrition expert since many of these foods are vegetables and fruits, and reduce meat and processed foods, a person will be healthier, but not on the basis of ph.

  There is no evidence it prevents osteoporosis in menopausal women and that cancer grows better in an acid environment. It is true that many alkaline foods are good food choices and should be eaten in any healthy diet, but not because of the ph!

F. The top 10 diets for 2019 searched by google (MedicineNet Health News)

 1. Intermittent Fasting diet

    Intermittent or cycling diets may mean only eating 20-25% of the recommended calories or restricting the number of hours when eating is permittent (usually 8-12 hours). It also may mean not eating at all on certain days. This diet appears to induce weight loss, reduction of cholesterol, reduction of insulin resistance, lower blood pressure, and other health benefits. www.Medicinenet.com

  2. Dr. Sebi diet

  This comes from a Honduran herbalist who specifies certain choices in a vegan diet mixed with a plant-based diet. He also pushes supplements to alkalinize the blood, which as stated above is not possible (only the urine can be alkalinized). It is another detox diet.

  3. Noom diet

  This diet app is a behavior modification diet that includes tracking and logging body weight, blood pressure, recommendations for exercise, blood sugar, and other behaviors.

  According to an article in Scientific Reports found that 78% of those who followed this diet long term lost weight. According to some nutritionists, it makes sense to approach a diet (regardless of type) in this manner.

  50 million people follow this plan woldwide, according to Mayo Clinic. It is called the Weight Watchers diet for millenials, since it pairs individuals and links them to a goal specialist. One can access the app in the usual manner.

  4. 1200 calories diet

  If a person wants to lose one to one and half pounds per week, they can limit their calories to 1200. There is evidence that reduced calorie intake is associated with a reduction in cancer, heart disease, and diabetes.

  5. The Golo diet

 This diet is based on balancing hormones (insulin) and keeping blood sugar stable using mostly low glycemic foods such as fruits, vegetables, healthy fats, proteins, and whole grains. This is a natural plant and mineral based formula in a capsule.

   6. The Dubrow interval eating diet

  This diet includes a low carb diet with intermittent fasting. According to Eatright.org it stabilizes blood sugar, boosts fat burning, increases energy, and slows the aging process, however, it may or may not help lose weight depending on the number of calories consumed daily.

7. The Sirtfood diet

   This diet is said to stimulate the SIRT gene, which occurs when polyphenol containing foods are consumed such as dark chocolate, red wine, berries, olive oil, walnuts, soy, turmeric, parsley, red onions, coffee, and kale. This stresses cells which in turn stimulate the Sirtuin 1 gene, which is involved in many metabolic processes including cellular regulation. Some call it the “skinny gene”, which helps burn fat and lose weight. Adele, the famous singer, lost weight on this diet, if that is any endorsement.

8. No carbs, no sugar diet

  This is a highly restrictive diet cutting out important food groups, such as high fiber vegetables, fruits, grains, and beans. There are medical journal articles that support this type of diet that will allow weight loss. This diet is much more restrictive than just a low carb diet, and taking breaks from restrictive diets such as this is probably a good idea. 

9. Endomorph diet

  For people who have considerable muscle, are full figured, and are “big boned”, are suited for this diet according to the American Council on Exercise, who state that these people tend to gain weight easily. This diet recommends protein, vegetables, healthy fat, and smaller amounts of high fiber unrefined grains. They should limit “white” foods—rice, potatoes, etc, (starch), processed foods, red meat, salt, and fried foods.

10. J. Lo diet

  Jennifer Lopez promotes lean protein, fish, nuts, berries, complex carbs, such as brown rice, sweet potatoes, oatmeal, and quinoa. Of course, she has a trainer that works her out daily as well. She and her famous New York Yankee fiancee’, Alex Rodriguez promote no carb, no sugar diets as well.

  Of course, there is no endorsement by most medical experts except to say, that the common theme in most good diets includes balance, reduction of calories, limited red meat, and processed foods, plus a large part of the calories dedicated to vegetables and fruits.

  Tricking the body into forming ketones, stimulating certain “skinny genes, taking some internet site’s vitamins and other products is a gimic to take the public’s money. These 10 diets were presented because Medicine.net claimed these were the top 10 diets googled in 2019, which do not mean they are better than common sense dieting.

www.medicinenet.com on 12-4-2019

G. Best diets of 2019 (U.S. News and World Report)

  For the third year in a row, the U.S. News and World Report has named the Mediterranean diet as the best diet overall. The DASH diet and ketogenic diet were close to the top.

  These results are based on surveys, but are picked by nationally ranked nutrition experts from the health division of the magazine. They shy away from trendy diets since there is not as much solid research and staying power. They considered 7 criteria for selection of the best diet---ease of following the diet, ability to produce short-term and long term results, nutritional completeness, its safety, and its potential for preventing and managing diabetes and heart disease.

  (WW) Weight Watchers diet plan was in 4^th place, which assigns point values to foods, with more nutritious choices having fewer points. These programs are good for people who need structure and support.  

  Other awards include:

 Best weight loss diet-WW –Weight Watchers with emphasis on low calorie and vegan diets. Jenny Craig (prepackaged low cal meals along with consultation and support) was the in second place.

Best fast weight loss diet went to HMR-meal replacement shakes, along with fruits and vegetables. Daily diet plans are provided online, a weight management and lifestyle plan.  

Best diet for healthy eating went to the Flextarian diet (plant based) and the MIND diet (combines Mediterranean and DASH)

Easiest diet-Flextarian diet;

Best diet for diabetes-DASH and Flextarian

Best heart healthy diet-Mediterranean and DASH

Best plant based diet-Flextarian.

H. Alkaline drinking water and other products for dry mouth syndrome

  Most alkaline water products have ph levels in the range 7.5 and higher. There are a few bottled waters that are alkaline such as Zephyrhills(7.7), FIJI(7.8), Evian(7.4), Nestle Pure Life(7.3), Volvic(7.5), Poland(7.2), and Voss(7.6), Dasani(5.6), Aquafina(6.0), and Alkaline 8.8. Click on this website for 10 spring waters that are alkaline:  www.tenspringwater.com 

  Using alkaline water helps prevent dental decay because bacteria in the mouth thrive in an acid environment, and most foods are acidic. Frequent dental hygiene visits are highly recommended.

  I have written a report on dry mouth a couple of years ago, and if you have the probem, I highly recommend clicking on my website to read the report:

www.themedicalnewsreport.com #72

  The body’s ph is 7.3-7.4. a neutral ph is 7.0, therefore the body is slightly alkaline. Acid ph foods are very erosive to the teeth, and eating alkaline food and drinking alkaline water may have some value. Although it is quite difficult to change the body ph, diets and water are being recommended extensively with little research to back up their claims. However, manipulating the mouth ph is much easier. Not having normal saliva sets the teeth and gums up for bacterial overgrowth which promote decay and gum disease. I have the problem and use Stella Life oral spray at night.

The British Dietetic Association named the alkaline diet as one of the 5 worst celeb diets to avoid in 2018. Extensive research has proven no value to forcing an alkaline type of diet on people.

Oral moisturizers

Biotene

Salivart

Stella Life

When I researched how many products are recommended for dry mouth that have an acid ph., I was amazed how many had a very acid ph. Biotene products are probably the most popular, but the ph of their products was an amazing 6.1, a very acid ph. I turned to StellaLife.com moisturizers and find it a better choice, but people need to talk to their dentists and dental hygienists about choices. I would pick an alkaline spray and drink alkaline water to keep the mouth more alkaline.

I. Detoxification defined

  Detoxification is considered alternative medicine and are  totally unproven to affect the long term health of humans.

  Proponents believe that the body has toxins that accumulate and have adverse health consequences. The alkaline diet is in this category. Fasting is very common as is juicing. Food coloring, pesticides, preservatives flavor enhancers, meat tenderizers, etc. all are thought to accumulate and using these techniques will theorectically rid the body of them.

J. Colon Cleansing

Buyer beware!

High colonics are more popular than one might think and has been around for centuries. There is no scientific evidence they are of value and can cause complications. In fact, interfering with the colon’s bacterial strains can have adverse effects.

  Bacterial flora in the gut is the “2^nd immune system. The bowel contains approximately 3 lbs. of bacteria that are critical for bowel and body health. Washing them out is not recommended.

  Complications of high colonics include perforations of the colon, electrolyte malfunction, flaring of bowel disease, abscesses, infection from contaminated equipment, and severe cramps.

  Coffee and herbal colonics are particularly popular. Why? Most of these types of “health trends” are all about a person taking control of their own bodies with an honest attempt to do good things for their body. Some of these trends are almost cultest and these people really believe they feel better. The placebo effect is clearly at work. 

  There are many ways to treat constipation and allow frequent bowel movements. Fiber products are plentiful and are gentle and effective. If they are not, seek medical assistance. Chronic constipation should be evaluated.  Stool softeners without laxatives are effective as well.

K. Removal of old mercury dental fillings

  People are still having the mercury amalgams (old dental  fillings) removed from their teeth to rid the body of heavy metals. It is a good way to line the pockets of dentists. It is not necessary and provides no health benefits according to the research I consulted.

L. Chelation treatments

   Chelation treatments are only to be used to remove  heavy metals from the blood in poisonings. Lead, mercury, iron, and arsenic poisoning are the most common metals requiring chelation therapy with EDTA, DMPS, TTFD, or penicillamine and are administered by medical experts in the hospital to bind these toxic metals which then can be excreted by the body. Kidney damage can occur and even death if not performed by expert physicians.

  The FDA warns against any chelation concoction sold over the counter as dangerous and not recommended. The FDA has no jurisdiction over these products. Quacks have treated heart disease with these products for decades, and the American Heart Association has stated there is no evidence chelation has any value in treating heart disease. Even some savory characters have treated autism with this method. The CDC has reported deaths of children treated chelation.

M. Activated Charcoal

Activated charcoal has been a mainstay in poison treatment for decades due to its effectiveness in absorbing chemicals and drugs following overdoses. In recent years internet sites are touting this product as an antidote for all types conditions. Use of products that bind specific substances in the stomach should be used only by specialists who have experience in poison control.

  Activated charcoal has popped up in juices, toothpaste, face washes, beauty products, etc. to “detoxify the body”. Health food stores and drug stores are claiming to aid intestinal cleansing, while there are normal or “good” bacteria that have important bodily functions and assist in the immune system.

  These “detoxifying” charcoal products that are marketed in capsules and sold make claims that are unfounded. In attempt to relieve intestinal gas and bloating, far more harm could occur considering the delicate balance of the bacterial flora.

Charcoal acts like a sponge and can bind many important nutrients, therefore, gastrointestinal specialists do not recommend the use of charcoal. 20-30% of people who take these products will vomit shortly after intake.

  In the stomach, activated charcoal soaks up most of the molecules it comes into contact with, preventing absorption relieving gastrointestinal gas and bloating. Results from several studies are mixed from the 1980s.

  The side effects are a black tongue and roof the mouth, nausea, and vomiting in a large percentage of people, according (20-30%). Some have chronic constipation.

  Studies have shown that it is ineffective in absorbing alcohol and heavy metals. They can interfere with absorption of any medications, vitamins, and minerals being taken.

JAMA, July 23, 2019

N. Fasting diets (fast mimicking diets)

   Fasting diets promotes cell regeneration, as described by some. It also can make a person lose weight.

  Any diet can be successful when it reduces calories. That is true according to this journal report, but the key question is, is it going to promote long term health? Although ketogenic diets have not have not been studied regarding all-cause mortality, low carbohydrate diets have shown increased mortality.

The fasting can run for 1-3 days. There are many different versions and time tables for these diets. There is evidence that going several hours without calories each day gives the body time to digest and metabolize the foods we eat. Drinking a great deal of water is a must in any of these diets. There is scientific evidence it can help lose weight with the resultant benefits.

Restriction of carbohydrates, as in the ketogenic diet, can transiently improve glycemic control (blood sugar levels). Actually, glycemic control and reduction of insulin resistance can be achieved with any diet that is restricted in calories and has healthful carbohydrates such as legumes, whole grains, and fruit, even in the absence of weight loss.

  The ketogenic diet is different in that all carbs are eliminated to put the person into ketosis (an acid ph environment from breakdown of fats when protein and sugar is not available for metabolism) with the consumption of high levels of fat (generally exceeding 70% of calories consumed). Low intake of protein and glucose shift the metabolic breakdown of foods into energy. This creates ketones as fats are broken down to fatty acids instead of carbohydrates for energy.

  By moving the metabolism from gluconeogenesis  (burning of carbs) to fat burning, the fats are used as energy, and the breakdown byproduct of fat is an acidic compound that gives the breath a “fruity” scent called ketone bodies. Starvation also causes ketosis. It is quite difficult to keep the diet limiting carbs and protein to less than 30%.

  It is important to note that high fat diets can raise the LDL-cholesterol and apo-B-containing lipoprotein levels even in the face of weight loss.

  Another important aspect for maintaining a ketogenic diet is not consuming high fiber and unrefined carbohydrates. These foods promote health and reduction of cardiovascular disease and cancer, so a ketogenic diet misses out on these important nutrients. All experts recommend avoidance of highly processed, refined carbohydrates (sugar, white bread, candy, etc.).

  Perhaps readers have heard about ketosis in diabetics. Ketoacidosis occurs when diabetics do not replace the insulin missing in the disease, which is necessary to metabolize sugar, so fat starts being burned making the ketones. This is a grave condition in diabetics and must be reversed.

  In the ketogenic diet, care must be taken to follow the levels of ketones and not let it get out of control. Diabetics would do well to avoid this diet. Always discuss dietary changes with the physicians to be sure it is safe for any individual patient.

  This diet can even come with a breathalyzer to determine the amount of ketones in the body.

  The induction period of a ketogenic diet may create a keto flu syndrome (fatigue, weakness, and gastrointestinal upset), however, deadly consequences can occur rarely such as cardiac arrhythmias from selenium deficiency. Other documented side effects include kidney stones, constipation, bad breath, muscle cramps, headaches, diarrhea, restricted growth, bone fractures, pancreatitis, and multiple vitamin and mineral deficiencies.  

Link to Alzheimer’s disease ?

   Patients with early Alzheimer’s do not metabolize carbohydrates well, and therefore a faulty way to use foods for energy. Moving to a diet that increases metabolism with fats and the creation of ketones may be a good energy source. If current studies hold up with other independent studies, ketogenic diets may have its place in preventing early dementia, but it is too soon to be recommended.

Journal of Alzheimer’s disease, July, 2019

P. Other Fasting diets

  The journal of Cell Metabolism suggests that calorie restricted fasting about 5 days a month for 3 months may promote longevity, and reduce risk factors in cancer, diabetes, and heart disease.

  Healthline.com states that there have been some small animal studies that show some benefit. They state that more rigorous research is needed to show benefit enough to be recommended. Fasting diets are catching on, but before considering one of them, I would talk to a physician.

Summary

  Everyone is looking for the “Fountain of Youth”, and many people value these techniques with little true evidence they work. These people are easily influenced by others who tout their benefit (J Lo).

  The body has it own purification system….it is called the liver, kidneys, lymph system, the colon. Before venturing out on any unproven alternative medicine diet plan, I strongly suggest a serious discussion with an experienced doctor, because concurrent diseases will greatly influence what a body can tolerate when venturing from the norm. Detoxification is a myth.

  Eating wholesome quality foods with a minimum of bad fats, excess sugar, fatty meats, processed foods with the major percentage of any meal consisting of vegetables an fruits will give the body all the detox ability it needs.   

  Losing weight is a serious medical undertaking if considerable weight is needed to be lost. Choosing a diet should be a decision between a motivated doctor (most are not) to make recommendations and team up with a nutritionist, and an exercise consultant. Medications are often helpful in curbing the appetite and are underused. I have reported on the latest medications for weight loss.

 It is a shame most doctors do not have time in their practice to spend to provide extensive guidance. Nutrition experts are available and might be a good idea.  Besides most doctors are not well trained in weight management and nutrition.

Wikipedia, Mayo Clinic

MedicineNet Health News, Dec. 24, 2019

2. MEDICAL UPDATES

   A. Dietary supplements for brain health and other issues; the rise of more quack methods

Brain health supplements

  To prey on those seniors who may be having some cognitive problems (memory, concentration, problem solving, etc.), there continue to be many ads for supplements that help brain health (Prevagen from the miraculous jelly fish), finally there is a good article on the subject.

  Authors of a study from Mt. Sinai Hospital, New York reported there is an evidence-based research project that could find no any reason to endorse any ingredient, product, or supplement designed for improving brain health. The authors did endorse a healthy diet as an alternative.

  Americans purchased some 85,000 different types of dietary supplement products annually, which accounted for more than $40 billion in retail sales in the U.S. This is especially true of older people.

  A recent survey reported that 81% of Americans aged 50 and older believe that dietary supplements are at least somewhat important to overall health. 69% currently take these supplements at least three times a week. Brain health supplements are but a small part of this multi-billion industry.

  The American Association of Retired Persons (AARP) Global Council on Brain Health released a report from an independent group of physicians, scientists, and scholars published online www.aarp.org 

  Research on Alzheimer’s started the motivation for the public to seek out products to help brain health. The U.S. Government Accountability Office started a website that gets into the specific evidence regarding individual supplements www.cognitivevitality.org 

  The website focused primarily on the 8 B-vitamins, D, and E, Omega-3 fatty acids, fish oil, coconut oil, Huperzine-A, caffeine, nicotinamide riboside, phosphotidylserine, curcumin (turmeric), flavanols, Coenzyme-Q10, Gingko biloba, apoaequorin (derived from jellyfish—Prevagen).

  Keep in mind these supplements are not regulated in any way by the federal government including the FDA.

  Deficiencies of vitamin B-12 and B-9 have been associated with cognitive problems, which can be a precursor to Alzheimer’s disease. But if a person has normal levels which can be tested for, supplements of these vitamins are not recommended for brain health even if Alzheimer’s patients.

  Small studies have implicated some value of the Omega-3 DHA (docosahexaenoic acid) may help those who already have mild cognitive impairment. These studies need much more replication before this is considered approved for use.

Groups to avoid supplements

  Those with certain health conditions should specifically avoid these supplements including those on blood thinners, those who take medications that affect the immune system, those undergoing surgery, and individuals with mild cognitive impairment.

  As always the experts always recommend that supplements be consumed in healthy natural foods. There are a few small studies that show some value in lowering the risk of cognitive issues with seafood. What is good for your heart is good for your brain!

  Some in these studies are adamant that these brain supplements do not work.  Medscape, June, 2019

Glucosamine (one of the good ones….maybe)

  Glucosamine is a common nutritional supplement used primarily for joint health,

relief of pain, and now even there is an observational study to test the value of reducing cardiovascular risk in those without known cardiovascular disease over a 7 year period.

  20% of 500,000 people in the U.K. took glucosamine regularly. Adjusted for other variables, the group had 15% fewer cardiovascular events, 22% fewer cardiovascular deaths, 18% fewer coronary events, and 9% fewer non-fatal strokes than non-users. These differences were stronger for current smokers.

  These results are biologically possible because glucosamine is an anti-inflammatory supplement, and previous studies have shown reductions in blood levels of C-reactive protein, a known inflammatory marker for multiple diseases.

Caution regarding success

  Since observational studies are the least valuable type of study, people who take glucosamine may just be those who lead a healthier life style than those who do not take this supplement regularly.

  Before any supplement can be recommended by any medical organization, more controlled studies are necessary. Forget ads for any dietary supplement, since there is no jurisdiction by the FDA. That is why no supplement can be advertised as being a treatment for any disease or disorder. British Medical Journal, May, 2019

The rise of quack methods for treating dementia

  An interesting article in the January 25, 2019 edition of JAMA emphasized the rise of so many dietary supplements on the internet, in health food stores, and spas that are completely unproven to be of any value to patients with dementia ot those worried that they might develop it because of fear or a positive family history. They called it “pseudo-medicine”, defined as supplements or medical interventions that exist within the law, that are marketed for helping these patients. I am not as nice! I call it quackery.

  The brain health industry makes an estimated $3.2 billion per year with their media blitzes. The public continues to forget the FDA has no jurisdiction over these supplements. What is even worse is that licensed medical professionals target their patients with unsubstantiated methods for treating and preventing neurodegenerative diseases. This includes intravenous nutrition, personalized detoxification methods, chelation therapy, antibiotics, and stem cell therapy.

  These practitioners may offer holistic and personal approaches and even state these treatments are backed by scientific articles that lack quality control, peer review, without control or placebo groups to compare with. Testimonials are a key method that should raise a red flag to anyone who sees these ads.

  Preying on desperate individuals is horrendous and should not be tolerated by our government, and yet the industry’s lobbyists have kept Congress from addressing this necessary evil. Bringing this to a person’s doctor may be of value to educate them. Next month I will discuss updates on treatment for Alzheimer’s disease!

Alzheimer’s Association International Conference, 2019 

B. Stem cells--unproven treatments

Weekly ad in Sarasota, Florida newspaper!

  More than 700 U.S. clinics advertise for unproven medical conditions using stem cell injections. In 2018, the FDA issued a press release that stated, “the potential for regenerative medicine has spurred major progress in stem cell biology over the past decade. But we continue to see bad actors exploit the scientific promise of this field to mislead vulnerable patients into believing they are receiving safe, effective treatments, when instead the stem cell producers are leveraging the field’s hype to push unproven, unapproved, illegal, and potentially unsafe methods”.  

  The majority of companies involve orthopedic procedures that are unproven. 608 clinicians were involved in these clinics. 30% were orthopedists, 16% anesthesiologists, and 11% Physical Medicine and Rehabilitation. These injections are not covered by insurance.

  Stem cell injections have already been stopped after failure to regenerate heart muscle after heart attacks. Why would it help elsewhere? 3 patients have become blind after stem cell injections for macular degenerations (1 in Florida).

  There is a class action suit in California representing over 100 patients who were harmed or treated fraudulently. Efforts to curtail these unscrupulous methods have not stopped these clinics from continuing to fleece patients with these injections.

  The International Society for Stem Cell Research has developed a patient informed consent form that include rationale for treatment, nature of the intervention, oversight, benefit, risks, immunosupression, adverse events, manufacturing methods and risks, cost, rights, alternatives, and data to prove success.

  The unproven nature of these methods makes it difficult to complain about medical malpractice lawsuits, because there is no accepted standard practice against which to judge clinics and their practitioners.

  State Medical Boards are not being as aggressive as they could. Why is the FDA not shutting these clinics down? Complaints are being investigated.

  It is sad that patients looking for a quick fix of stem cell and platelet cell injections for a joint issue or other medical conditions including Alzheimer’s disease are trusting these practitioners. Patients are not being fully informed regarding the lack of research to prove validity of stem cell injections, regardless of where they are harvested.

JAMA Network, August 12, 2019

Comment—people who have a medical problem are always looking for an easy solution, and somehow assume if it is in the newspaper, on television, and the physician peddling the treatment has an M.D. (or D.O.) behind his name they are assumed credible. There are flim-flam people in every profession, and medicine has its fair share of them. Healthcare today has forced doctors into worrying more about the bottom line rather the welfare of their patients.  

  Do the research before accepting a treatment, assuming an internet site has legitimate drugs that are effective. Talk to a trusted physician about any fringe treatments before even walking in the door. This is no time for the public to be naïve.  

  C. How many daily steps are associated with  lower mortality?

  The public widely believes that 10,000 steps a day are necessary for health benefits.

  2700 women were followed for 4.3 years. Compared to the least active women, the active group had 46%-66% lower mortality when taking 4400, 5600, and 8400 steps per day. They experienced 46-66% lower mortality over those 4.3 years. Those walking from 4400-7500 steps per day had the lower mortality, however over 7500 steps a day did not increase benefits.

  Approximately 2000 steps are necessary to walk a mile, therefore, to lower mortality, one must walk a little over 2 miles a day to lower mortality, with 7500 steps not providing extra protection from death.

  Of course, the speed of walking determines fewer or more steps, but brisk walking is all that is recommended to providing health benefits. Aerobic activity is also known to reduce all cause mortality, so getting the heart rate up walking is encouraged.

JAMA, Internal Medicine, May, 2019

  The new Apple watches and other smart watches give people motivation to not only exercise but follow their progress. It is an amazing advance in personal achievement in exercise. Monitoring the pulse and even performing an EKG on the watch is a great advance plus an automatic 991 call if you fall. Yes! I have one!  

  D. The effect of menstrual periods on productivity in women

  The menstrual period has a significant effect on work and school productivity for women, not to mention quality of life.

  A Dutch study surveyed 32,000 women ages 15-45 about the above issues. They were broken into 2 groups—#1-averaged 30 years old and #2- 22 years of age.

  The absenteeism because of menstrual-related symptoms occurred in 11% in #1 group and 20% in #2 group.

  Absenteeism every menstrual cycle occurred in 3% of both groups. Loss of productivity while at work or school was reported in 83% of these females and highest in ages 15-20.

  Abdominal pain was the most distressing symptom followed by headache and backache.

Treating menstrual symptoms

  The use of an IUD containing levonorgesterol-releasing device (a form of progesterone) reduced absenteeism and productivity in both the workplace and school.

  Education about the use of localized heat, NSAIDs (Aleve, ibuprofen, etc.), exercise, the use of IUDs containing estrogen and progesterone can be very valuable.

  If symptoms are persistent after 3 months, consultation with a physician for an evaluation of disorders such endometriosis or other gynecologic issues.

 Bristish Medical Journal, June, 2019

3. Minimally invasive, robotic knee replacement surgery-new technique

Having had both my knees replaced (at the same time), it was great to see that now the knee can be replaced in certain candidates with smaller incisions, even robotically.

  The formal name is knee arthroplasty. Less major knee procedures have been performed endoscopically for years. The new procedure is not performed endoscopically, rather, it uses smaller incisions to accomplish the same result. In some cases, physicians are using robotic techniques to perform the surgery, which in the right hands can be more precise in placing the prosthetic knee .

  The long incision (8-10 inches) for the open procedure takes a long time to heal and finally mature. For the knee to bend maximally that scar has to be mobilized (not stuck to the knee cap).  Preventing that wide open incision is a great advance.

  Here is a drawing demonstrating the difference in length of the incisions. On the right, is an example of robotic knee surgery.

Technique

The arthritic portion of the knee joint is shaved flat to allow the use of the plastic and metal parts of a total knee replacement. A plastic button may be used on the inside of the knee cap as well. Below is an open procedure photo.

Minimally invasive techniques can be performed through a 4-5 inch incision. The dissection of the tissues required is less than the open procedure, an important advance. The quadracep (thigh) tendon and muscle is not split with the less invasive procedure (a major improvement).

  The posterior cruciate ligament may be retained or replaced with a polyethylene post to provide stability to the knee joint. (The drawing shows an arrow pointing to the posterior cruciate ligament).  Pain comes from incisions in muscles and tendons, therefore, less muscle cutting and less pain may occur. However, most of the pain really comes from mobilization and exercises to return the range of motion to the knee.

Another advance is the use of tantalum, similar to bone paste, which is used to fuse the implant to the bone ends preventing the need for cement to accomplish the same procedure. Using cement requires a tourniquet during surgery, and not using the cement prevents the risk of damage from cutting off the blood supply to the leg during surgery with a tourniquet. This is now used in the open procedure as well. This speeds recovery.

  Candidates for the newer procedure usually are thinner, healthier, and must be highly motivated to perform the difficult rehabilitation. Most of these candidates have not had previous replacement surgery.

  Advanced arthritis of the patella (knee cap) may require a titanium cap on the undersurface of the patella. Those who are very muscular, have deformities of the knee, and those with health problems may heal slower making this procedure less desirable. Although, choice of candidates relates more to the experience of the surgeon and what he or she is willing to accept as a surgical candidate.

  The ultimate results of surgery are no better than the open procedure, but healing may be faster allowing more aggressive rehabilitation, which is a must to get full motion back into the knee. Over time, this new technique may prove more advantages.

  Complications are the same (bleeding, infection, failure of the implant, etc.). Having a very experienced surgeon is very important.  

  I reported on the open total knee replacement surgery. Please click on www.themedicalnewsreport.com #79 for a more complete discussion on this procedure, exercises before and after surgery, and several photos.

4. Cancer death rates taking a dive; Treating chronic pain in cancer patients (survivors)

Cancer deaths

 The American Cancer Society publishes annual statistics on presenting the rates of cancer in every body part. For a complete look at the stats, click on: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf

  It was published in Ca-cancer Journal.

  Several factors are contributing to the success in reducing deaths from cancer in the U.S. This good news came from reductions in death rates from the 4 most common cancers—lung, colorectal, breast, and prostate.

  1) There has been good news about cancer since new biologic (targeted) therapies have been used primarily in advanced cancers to prolong patients’ lives.

  2) Routine screening for cancer continues to reap benefits.

  3) Fewer smokers equate to fewer cancers.

  4) Low exposure spiral CT scans screening of the lungs on smokers and previous smokers equates to a drop in death rate of 20%.

  5) Vaccines are now preventing genital cancers. Precision medicine is making its mark. 13% of all cancer is now caused by infections worldwide. HPV, hepatitis B and C are the sources.

  6) Genetics is allowing women to decide to prevent breast and ovarian cancer in those with BRCA gene 1 and 2 gene mutations by prophylactically removing their breasts and ovaries. Other genetic tests can now allow for specific treatment in several cancers in specific patients.

  Even though screening does create morbidity (harm from false negative cases), colorectal, prostate, and breast cancer dropped considerably but plateaued in 2018.

  Immunotherapy has dropped the death rate in melanoma 7% per year in those under 65.

  THE LARGE DECLINE (29%) IN CANCER DEATHS COMES FROM 2.9 MILLION DEATHS AVERTED FROM 1991-2017. There was a 2.2% drop in death rate in just one year (2017-2018). Lung cancer death rates dropped 5% from 2013-2017 in men, still the leading cause of death from cancer.

  We still have a long way to go since 1.8 million new cases and 606,000 deaths in 2020 are predicted. Liver, kidney, oropharyngeal (mouth and throat) and pancreatic cancer continues to increase, but in women liver cancer deaths have leveled off.

  Hepatitis B and C are the main cause of the increase in liver cancer, although obesity,  smoking, and excess alcohol consumption are serious risk factors. Hepatitis C testing continues to be low (14%). Diet, obesity, type 2 diabetes, smoking and other factors are some of the factors in pancreatic cancer. 

Estimated New Cases of cancer in 2020

Cancer Survival statistics (5 year survival)

  68% of whites survive cancer 5 years whereas blacks survive less well (62%), primarily due to a later stage of diagnosis in blacks.

  Prostate cancer has the highest survival rate (98%), whereas melanoma of the skin (92%), breast (90%), follow.

  The lowest survival continues to be pancreatic (9%), liver (18%), lung (19%), and esophagus (20%).

  Leukemias and lymphomas continue to be better treated greatly increasing survival rates at 5 years. Below is a chart regarding those cancers that occur from a blood cancer. 176,200 cases occurred in 2019 according to the Leukemia and Lymphoma Society. 64% of patients with leukemia live 5 years or more. 93.7% of patients with lymphoma live 5 years. This is a quadrupling of survival since the 1960s.

Incidence of colorectal cancer have dropped by 59% in men and 53% in women by 2017 since 1980. This is primarily due to removal of premalignant or potentially future malignant colon polyps.

  Declines in smoking (29% decrease since 1991) are making a big impact in mortality rates while the increase in obesity is cancelling out much of that progress.

  Although heart disease is the most common cause of death (cancer is #2) in the U.S., cancer is the most common cause of death in Hispanics and Asians. It is the second most common cause in children 1-14 (accidents are #1).

  Childhood cancer caused an 80% death rate 50 years ago, and today 80+% survive cancer today primarily due to specific treatments in leukemia causing near 100% remission rates and 80% remission in children and adolescents.

  Addressing the obesity epidemic, improving the diet of America, continued efforts to reduce smoking (including reducing vaping), less abuse of alcohol, and other behavioral issues can reduce cancer incidence by 50%, it is estimated by the CDC.

The American Cancer Society has a great resource for patients undergoing cancer treatment. This area has been neglected in the past, and is a vital aspect of improving cancer survival by eating the proper foods. Please consider purchasing this 288 page book if a loved one is facing cancer treatment.

Reference-- The American Cancer Society--Facts and Figures 2020.

Treating cancer pain

  30-40% of cancer survivors have chronic pain, sometimes months and even years, after treatment. The area of treatment from radiation or surgical scarring, reconstructive procedures, lack of return to normal function, chemo related neuropathy, and aging issues to boot are some of the causes of pain.

  I had cancer in my throat in 1991 and twice a day radiation therapy for 7 weeks, and have had significant pain in my neck and upper shoulders from radiation fibrosis and deterioration of the cervical spine, nerve damage, muscle wasting of neck and upper shoulder muscles leaving me with difficulty keeping my head erect, shoulder and back pain necessitating pain management procedures (primarily epidurals and cervical spine surgery). Constant exercise, yoga, and perseverance have kept my quality of life high.

What works in cancer pain?

  A study of 81 clinical trials which included 10,003 survivors received various pain medications, anti-seizure meds, *NSAIDs, and the most effective medications non-opioid analgesics, lidocaine (intravenous), codeine plus aspirin, and Lyrica (and Neurontin) for neuropathy.

  The most effective was ziconotide (Prialt) for severe chronic pain. This is a potent drug used under special circumstances, since it is 1000 times more potent than morphine. Dezocine (Dalgan) similar to pentazocine is also effective. Declofenac (Voltaren) an *NSAID is also very effective. *NSAIDs can be just as effective as opioids for chronic pain. Monitoring of the kidney and liver function studies should be performed when taking any of these medications, even Aleve and Tylenol.

  I have found that Aleve plus Tylenol can be as effective as Tramadol, a weak short acting opioid, without the euphoria. Cymbalta, an SSRI anti-depressant can help in certain cases of neuropathy, and there are other non-opioids can be tried such as gabapentin (Neurontin) and pregabalin (Lyrica), which are normally prescribed for neuropathy.   

 *NSAIDs=non-steroidal anti-inflammatory drug (Aleve, ibuprofen, etc.)

Negative consequences of prolonged use of opioids

  Studies have found that prolonged use of opioids causes hyperanalgesia (excess pain), which argues against the prolonged use. Those who take opioids with this side effect actually make the pain worse. More research is needed to find out which patients are likely to develop this hyperanalgesia syndrome.

  The practitioner needs to take into consideration all of the above factors when treating chronic pain in cancer survivors.

  I have reported on all the major complementary treatments to be used in chronic pain patients including, chiropractic, acupuncture, physical therapy, regular exercise, massage, yoga, tai-chi, and many more (available in the subject index of my website www.themedicalnewsreport.com

  The use of cannabis is being added to the list of additional complementary treatments. Much research is needed, and now that the federal government has approved CBD (cannidibiol), the non-THC form of marijuana, used in certain childhood seizure disorders, it is being purchased aggressively, but how many are helped is still being studied.

Factors aggravating pain (psychological, physiological, cognitive, and situational factors)

  Many factors influence pain including centrally mediated symptoms such as fibromyalgia, chronic fatigue syndrome, sleep difficulties, impaired cognition that can all occur simultaneously with chronic pain. Chronic pain can occur with traumatic events creating PTSD, sexual or physical abuse, etc.

  There is a disorder called central hypersensitivity syndrome, which applies to people who have over-stressed their neuroreceptors because of chronic pain which creates heightened chronic pain. This may apply to certain cancer pain patients. 

  Of course, mental illness creates serious overlap in the perception of pain and how medications cross react with psychological medications. Without considering all these factors, pain is treated one dimensionally and less effective. Pain management doctors are reluctant to prescribe anxiety meds (benzodiazepines) in addition to opioids because of the danger of increasing sedation and actual overdose.

Summary—Non-opioids are as effective as opioids in chronic pain for cancer survivors.

  For an extensive discussion on pain, consult my Subject Index in my website  www.themedicalnewsreport.com

        Journal of Clinical Oncology, July, 2019

5. Updates on Drug Costs

    1- Attempts to curtail drug costs ongoing

    2- Medicare Part D changes for 2020

    3- Need for better regulation of dietary supplements

    4- Drug importation from Canada

1. Drug costs

  The Trump Administration has been hard at work trying to deal with Big Pharma since taking office.

  There are many issues are on the table, and unfortunately previous laws by former administrations have made it exceedingly difficult to change them since there are laws on the books protecting cost reform on Big Pharma.

  Times have changed and medical costs have skyrocketed with this protection from tampering with costs. Our Congress must change the laws and, as I have said many times, get the lobbyists out of Washington D.C., who have corrupted our politicians with campaign finances.

  a. Changing the rules on biologic drug price protection and other news

  There are far too many medical bankruptcies in this country, and the cost has not been curtailed because of some administrative actions in 2006. A good example are the immunotherapy (biologic) drugs to treat immune diseases (rheumatoid arthritis, psoriatic arthritis) and cancer. These drugs such as Keytruda, Humira, and Enbrel are protected from interference with drug pricing thanks to a Congressional deal. These biologic agents were given a green light from the Obama Administration for 10 years of freedom from any cost constraints. Currently there are attempts to remove that protection. These medications cost over $100,000 a year. Even with a 20% co-pay, this is a big hit for most patents.

  These drugs are costing patients and the federal government a large percentage of the overall cost of all medications.

  Bipartisan support for this change is part of the North American trade agreement between Mexico, Canada, and the United States, USMCA. With this trade agreement, this will be a huge setback for Big Pharma by removing the protection of these biologic drugs from other companies to produce biosimilar drugs at reduced costs. Without this protection created by the Pacific Rim agreement under the Obama Administration, now stopped by the current administration, there is no protection, and costs can now be reduced with competition. But they will still be too high.

  Big Pharma has been raising prices as much as 20% per year. Many patients have been rationing their drugs or even gone without them (such is the case for diabetics needing insulin).

  To give the reader a concrete example, the fabulous biologic, Gleevec, which controls chronic myelocytic leukemia (CML), was $15,000 per year in 2003 when it was first introduced. Today, the cost is $146,000 per year!

  This is financial toxicity, when the average annual household income is $63,000. When a lot of these drugs lost their patent, recall I described what Big Pharma did…they paid the generic companies to delay production and distribution of the generic drug. When the generic drug came out, curiously, it was only $6,000 a year cheaper. In Canada, the brand name product is only $38,000.

  b. Discount pharmacies

  Discount pharmacies should be explored as the cost with them could be less that the co-pay for Medicare (25%).  Insurance does not cover GoodRx, Blink, WellRx, etc. Still it could be a major savings.

  c. Passage of the USMCA

 When the Trump Administration teamed with the Democrat and Republicans for passage of the *USMCA, it will remove pricing protection from Big Pharma regarding biologic drugs, as mentioned above. The trade agreement will also include allowing cheaper prescriptions from out of the country. Canada is the main source of cheaper drugs.

 *USMCA=U.S. Mexico and Canada Trade agreement

2. Medicare Part D changes

  60 million Americans are covered by Medicare (2019), and 45 million participate in Part D.

  There is some good news in the drug prescription plan for Medicare Part D. There are some changes in cost to the patient in 2020.

Review the part of Medicare

  Recall Part A covers doctors and hospital costs, Part B is for coverage of the 20% that Part A does not cover (Plan F is the best coverage), and officially there is no Part C (which is essentially Medicare Advantage), but Part D coverage provides a very difficult to understand provision for most prescriptions medications. The exception is Part B coverage for medical devices (wheel chairs, breathing machines, CPAP, etc. and medications administered in doctor’s offices or outpatient facilities.

There are three parts to Part D—

1) The initial coverage with certain copays based on a number of tiers (6).

2) The gap coverage-known as the “donut-hole”, that greatly increases the cost of the drugs to the patient starting at $3700 and ending at $4950. This gap coverage has been partially closed in the past year, protecting millions of participants.

3) The third phase is the catastrophic coverage and is limitless. The government is responsible for the major portion of this phase and costs us (the taxpayer) $85 billion a year for the 45 million beneficiaries.

  In contrast to the other parts of Medicare, Part D is run entirely and administered by private insurance plans with only regulatory oversight by the federal government.

  The law prohibits the feds from directly negotiating or setting drug pricing in Part D. The feds expected competition among private plans to enhance and lower prices, but it didn’t happen. (Who agreed to that????)

  There was little incentive for private plans to manage costs, particularly for high cost beneficiaries. Thanks to the concern that Part D would even get off the ground in 2003, the feds desired an overall plan for seniors even if they (the feds) had little control over it (the problem). They asked the fox to look out for the chickens in the hen house.  

  The main risk went on the shoulders of the private insurance companies, and that is why our Congress gave the insurance companies the reins with little interference from the feds. There are now 948 individual private plans for Part D, according to the Medicare website.

  In 2020, the catastrophic phase starts at $6,350 for out of pocket costs for the benefactor and $9,719 total drug costs (that includes subsidies from the federal government).

  At this cost limit, the federal government steps in and picks up 80% of the costs, with the insurance company is required to pick up 15% and the patients 5%. So all the heavy lifting switches to the federal government off the backs of the private plans. Back in 2003, the cost to the government was around $10 billion but is now $85 billion, because the design of the plan has not kept up with the marketplace’s outrageous prices.

  Nearly half of those 45 million Medicare participants will reach the catastrophic phase of Part D.

  Private plans bear little responsibility for the donut hole, with the main burden on the patient.

  The Acountable Care Act in 2018 and a bipartisan Congress addressed this problematic cost sharing, and did some “filling in” of the donut hole to reduce the extreme responsibility of the patient.

Changes for 2020

  The standard deductible for 2020 has risen from $415 to $435 in 2020. The initial coverage has increased from $3, 820 to $4020.

  Beneficiaries will be responsible for 25% of the cost in the donut hole for brand name drugs and 75% of generic drugs. After 2020, the gap phase (donut hole) will be phased out and patients will go directly to catastrophic coverage.

  Now, what I have been driving at!! With this enormous cost increase to the federal government, the feds have to modify what the private plans are responsible for. Right now, the private plans pay for 34% of the plan overall, but with the 80% of catastrophic coverage on the backs of the feds, the Congress must go back to the private plans and renegotiate their cost responsibiltites with protection to the patient regarding premiums, deductibles, and co-pays.

  It is critical to talk to your congressman and encourage them to deal aggressively with this huge issue.

NEJM, Dec. 19, 2019

A critical note to Medicare beneficiaries!

  Depending on the actual medications a patient is taking in any one year, it can increase or decrease the insurance premiums, deductibles, and co-pays directly depending on the plan. This must be looked at by a certified Medicare person to look at the best plan each year based on the prescriptions a patient is taking.

  Finding alternative medications, over-the counter meds, and out of country or discount services (Good Rx and Blink), may allow a person to switch plans yearly. It is critical to contact a representative to discuss different plans as medications that are covered change, are dropped, or added. It can save a person considerable expense. Just one medication alteration can make a huge difference in annual premiums.

  When the enrollment for Medicare comes in November, be prepared to review the drugs that one is taking, and discuss possible alterations in one’s Part D coverage plan, even with the same insurance company. I have changed each year!

 3. Supplements—modernizing the dietary supplement industry—current law does not protect the public

  This industry is out of control, and our government has lagged far behind its responsibility to adequately protect the public from many dangerous supplements. Today, this is a $40 billion business ($4 billion in 1994) now that there are thousands of biologic and herbal supplements.

  A great number of these supplements are never evaluated by the FDA even though review is mandated by the New Dietary Ingredients provision under the Dietary Supplement Health and Education Act of 1994, a federal law requiring review of all dietary supplements.

  Finally, Congress is looking into this law and how to modernize the industry regarding safety. Recommendations have been made from the Harvard Medical School published in the NEJM, Dec. 10, 2019.

  Although their recommended changes would cost more to implement, they recommend that all supplement’s ingredients be reviewed before allowing the marketing of the supplement to the public.

  Currently, the FDA is only allowed to approve supplements for marketing, and only a selected subset are tested. The American public deserves protection from our federal agencies and if not the FDA, then create one soley for dietary supplements. It is all about safety, and many of federal agencies were created for safety…..safety of the air, water, soil, etc. why not dietary supplements? Remember the lobbyists? This industry has a strong lobbying force.

  Manufacturers are required to submit safety data establishing that the ingredients are “reasonably safe”. The industry must have a watch dog approach to be sure these companies are in compliance with the letter of the law. The reason these companies have slipped through the cracks is the fault of the FDA.

  An estimated 75,000 supplements have been introduced to the public since 1994, while the FDA has received adequate safety data on 250 new ingredients. Time to either clean house or kick some ….

 4. Drug importation from Canada

  The Trump Administration announced that states can import certain FDA approved prescription drugs from Canada announced by the head of Health and Human Resources, Alex Azar. Try to follow this, because it is a little compex.

  To ensure safety and quality, of course, there will be red tape to deal with to accomplish the transfer of prescription drugs. There has been concern that counterfeit drugs have been imported from China to Canada. This process will hopefully ensure these brand name items are authentic with no contaminants.

  Florida Govenor Ron DeSantis is already in the working on this for his state. Currently, there are several Canadian pharmacies in the state providing a go-between for drugs to be mailed to U.S. citizens.

  States will work with authorized wholesalers or pharmacies to re-label and distribute these drugs, which have authentic tracking numbers, ensuring the safe transfer from Canada to the U.S.

  Biologics, injectable or intravenous injections, and all controlled substances are excluded, however, there is already in the works a separate process to address these high priced items that have really hit the pocketbooks of Americans.

  Another group of drugs being worked on are those who have a large discount or rebate which have been going to to the national pharmacy management centers that store and distribute drugs to pharmacies instead of the patients. This is being changed by the Trump administration to some extent.

  There are side negotiations with Big Pharma to import their drugs from other countries into the U.S. at lower prices. The drug industry will likely work a deal to keep from being left out. Previously there are certain barriers in the private market prohibiting this process. Obtaining a national code system to ensure safety by the feds will apparently allow the drug companies to work around this barrier. Big Pharma says, with a national code, they could bypass the discounts or rebates, and lower the price to the patient.

  Generics are not included in this administrative effort. But even generics’ cost is way too high.

  Many counties in several states for years have been ordering Canadian drugs without these safeguards. Ordering online gives an individual no guarantee they will receive a drug that is bio-eqivalent with the brand name drug without contaminants even if it is supposedly coming from Canada. Counterfeit drugs are widespread for drugs like Viagra, etc.

  As one can see, there are multiple ongoing attempts to bring drug costs down, but the elephant in the room is the Congress must change drug laws and directly negotiate drug prices with Big Pharma, comparable the cost of other civilized countries. The Congress did it with Medicaid, and it needs to do it with Medicare.

Medpage, Dec. 18, 2019 (authored by Shannon Firth, Washington correspondent).

This completes the February report. Next month,

The March Report will be:

1- Acute Depression-new treatments

2- Medical Updates—dietary supplements, clinical medical trials, dry mouth innovations, insomnia drugs, antidotes for oral anticoagulants, screening CT scans for early lung cancer

3- Role of different eye doctors

4- Mental health of millenials and Gen-Xers

5- Brain Aneurysms

As always, stay healthy and well, my friends, Dr. Sam