The Medical News Report

December, 2018

# 83

Samuel J. LaMonte, M.D., FACS

www.themedicalnewsreport.com

Merry Christmas

Subjects for December, 2018

1. Medical Updates

    a) What type of attire do patients prefer their doctors wear?

    b) Report card on cancer screening rates in the U.S.  

    c) More dairy less cardiovascular disease? More grains less diabetes?

    d) Should patients take probiotics when taking antibiotics to prevent C.diff intestinal infections

    e) Flu symptoms-new treatment and updates, reminder about the new shingles vaccine (Shingrix)

    f) FDA restricts flavored e-cigarettes since youth vaping has doubled in a year!

2. Bad actors in Big Pharma, Law and Medicine—generic drugs being blocked; vaginal mesh lawsuits— sad stories

3. End of Life Issues—Death with Dignity--Physician-assisted suicide; Palliative Care/Hospice Care

4. Trump Administration working on Medicare drug costs—Negotiations for Part B and D costs

5. Anti-Depressants-difficult issues

Happy Hanukkah

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 physician, and decisions about your health require discussion 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

Subjects for December:

1. Medical updates

  A. What type of attire do patients prefer their doctors to wear?

  A recent study asked 6000 participants regarding their choice of attire for their doctors. The majority preferred primary care and in-hospital physicians to be dressed in white coats, while they preferred scrubs for surgeons and emergency physicians. These finding also correlate with satisfaction of physician care. This type of dress instilled the most confidence, and correlated with the perception that they were most knowledgeable, trustworthy, caring, and approachable for both male and female physicians.

  I always wore a white coat even if I had scrubs underneath my coat. Today’s physicians have become a little too laxed with their attire and forgot that they are looked up to as a professional and should look like one. By the same token the coats and scrubs must be clean and changed daily to prevent spread of infection.

  Today’s casualness in medical offices has perhaps interfered with the doctor-patient relationship, in my opinion, but I am old school!

 B. Report card on cancer screening in the U.S. and shared decision-making between doctors and patients about screening

  Cancer screening has saved more lives than any other type of healthcare program. There is, however, always risk with any test, but the benefit in most cases outweighs the harm.

  Over the past several years, in an attempt to reduce healthcare costs, there has been a federal attempt to downplay the value of cancer screening because of the harms from testing. Harm can come from false positives and false negative results, but the tradeoff is more cancers are being diagnosed earlier which usually translates in saving lives. Although it is of considerable concern any time a patient has complications, screening for the most common cancers should be considered by those eligible as it saves lives and be seriously discussed with their primary care physicians.   

  I have spent the past 7 years working on the American Cancer Society’s National Screening Guideline Work Group (40 years as a volunteer) that researches and publishes the revised guidelines for cancer screening for breast, cervix, colorectal, and prostate which account for over 40% of cancers and 20% of cancer deaths. Screening otherwise healthy populations is a primary tool for early detection and reduction of deaths even though the ultimate decision must be shared between patient and physician after education about the risks and benefits.

  The ACS and other medical organizations support screening but don’t always agree on certain criteria.

  We (ACS) recently revised the age to begin regular colorectal screening from age 50 years of age to 45, since we are seeing a rising number of these cancers in younger people based on solid research evidence. We also disagreed with the federal advisory group (USPSTF*), about prostate screening, and since then, the USPSTF* modified their stance on prostate screening due to recent findings and agreed with ACS (a decision between doctor and patient).

*USPSTF-United States Preventative Services Task Force

  This report is not however about the actual screening recommendations, but about how well Americans are following the guidelines for screening. These numbers are directly related to how clear national organizations make the screening guidelines to the public and doctors. Confusion about screening keeps people away.

  The desired targets are not being reached according to the CDC. The good news is that screening rates are increasing at least in colorectal cancer, but still need to be improved.

  There are factors that have kept the rates below target and they are: 1) those who do not see their doctor annually 2) those who have no direct sources for healthcare 3) younger Americans 4) those with lower income 5) those with less education 6) doctors are at fault for not spending adequate time on shared decision making (due to restrictions on time of visit).

Results of a study on percentages of screening:

1) Colorectal cancer( stool and colonoscopy)—actual 60%----target 80%

2) Cervical cancer(Pap and HPV)—actual 80%-----target 93%

3) Breast cancer(mammogram)—actual 70%-----target 81%

4) Prostate cancer screening rates (PSA)—actual 35%--target not found because it is not specifically recommended, rather it is only recommended after a discussion between doctor and patient.

  35% of men (50 and older) reported having a PSA in the last year. The reason organizations have not strongly recommended the PSA is that the test is not sensitive enough for cancer, since an elevated PSA can be caused by other issues and spur unnecessary biopsies. We really need a better test.

  These recommended screening tests are geared for the general population (without any family history or genetic markers for these cancers).

  High risk patients must have these tests even earlier and more frequent than these recommendations. Every woman should be extremely aware of changes in their breasts by frequent self-breast exams, and all people must examine their stools for changes in the color, change in bowel and bladder habits, and presence of blood that might point to a need for testing.

  Men also must be aware of changes in urinary stream, number of nighttime visits to the bathroom, and any other changes. It is the individual that is responsible for reporting any changes in their body to their doctor that might deserve evaluation.

  Currently, I am working on ACS screening guidelines for breast cancer who are at higher risk than the general population. Genetic markers, family history and dense breasts are some of the main concerns. ACS is also currently revising guidelines for cervical cancer, since the HPV test now appears to be even more valuable than the Pap test. These results will be available within the year. However, patients must insist on doctors taking more time to discuss the benefits and risks of cancer screening.  

Medscape Medical News, July,2018 as published in Preventing Chronic Disease in July.

C. More dairy… less cardiovascular disease? ; More grains less diabetes?

*A note about epidemiological nutritional research…most of the studies are observational and hard to control all factors. These studies may suggest a connection with causation. 

More dairy…less cardiovascular disease

  The Journal, Lancet, a European medical journal, reported on 130,000 participants, who consumed greater than 2 servings of milk(reduced fat or whole) or yogurt daily over a 9 year span had 20% less cardiovascular disease and deaths than those who consumed no milk or yogurt. Consumption of cheese and butter, however, did not reduce cardiovascular disease.

Times and study results have changed

  As I have previously reported on dietary factors and health outcomes over the past 5 years, it has become obvious that old ideas about certain foods were wrong. Examples are the findings of good cholesterol in foods. Eggs, for instance, at one time were considered unhealthy, and now within limits, they are recommended. This study did not see any differences between consumption of reduced fat or whole milk, which goes against most studies.

  Common sense about our dietary consumption is based on a person’s current health issues (i.e. hypertension, diabetes, hyperlipidemia, etc.) and should be approached with moderation. No one challenges that a diet high in fruits and vegetables are far more important than consuming dairy, occasional red meat, and other food products. It is a balanced diet with weight management and daily exercise that gives people the best chance for a healthy life. Lancet, September, 2018

More grains…less diabetes

  Eating more whole grains (rye, wheat, or oats) has been tied to having a lower risk of developing type 2 diabetes in a large study of middle-aged people in Denmark. Those people who ate the most grain had a 30% lower risk of developing type 2 diabetes as they aged and was published in the Journal of Nutrition. This is another observational study and results should not be considered gospel.

  The protection from grains of many health issues  exceeds the benefit of lowering the risk of diabetes. Replacing carbohydrates with grains has cardiovascular prevention advantages as well.

How grains work in diabetes protection

 Grains lower the risk of of type 2 diabetes by improving insulin sensitivity (resistance), which lowers the body’s glucose response because grains with carbohydrates are absorbed slower, thus slowing insulin release. This is thought to lower inflammation in the body which is tied to developing diabetes.

  Keep in mind all carbs are not created equal. Grains are the best carbohydrates to consume compared to refined and highly processed sugars.

  Prolonged low carbohydrate diets are not thought to lower cardiovascular disease, rather actually can increase all-cause mortality according to research. Cutting the “white stuff” out of the diet will help lose weight, but once the desired weight is lost, carbohydrates need to be reintroduced in smaller amounts.

  Dietary guidelines recommend 45-64% of the diet be high quality carbohydrates such as whole grains, ryes, oats, and muesli in association with leafy green vegetables. It is all about balance in the diet.   

  Europeans and Scandanavians, on average, eat much more grain than Americans (Europeans--27 grams per day, Scandanavians—33grams, Americans--16 grams). 1 slice of whole grain bread contains 40 grams and rye-50 grams.    

D. Should patients take probiotics when taking antibiotics to prevent C.diff. intestinal infections?

  A study in 2017 provided new information that taking probiotics when taking antibiotics will decrease the risk of an intestinal infection caused by the bacteria called Clostridium difficile (C.diff), a serious resistant infection causing severe gastrointestinal symptoms. Antibiotics are usually the culprit in bringing on this severe gastrointestinal illness with severe bloating, abdominal pain, and diarrhea.

  It is recommended that 20-50 billion units of probiotics be taken orally within 24-48 hours of taking antibiotics especially in hospitalized patients. Ask your doctor about this recommendation.

  I have discussed gastrointestinal bacterial infections and C.diff and probiotics:  www.themedicalnewsreport.com/60

High risk patients

  Patients who are immunocompromised, pregnant, in intensive care, have a prosthetic heart valve, or have certain gastrointestinal diseases (inflammatory bowel disease, or an ostomy) are more prone to C.diff. infections.

  A recent study stated that opioids given to these patients for pain increase the risk for a more severe disease, longer hospitalization, and higher readmission rates to the hospital. Opioids are also known to interfere with bacterial balance of the intestine, and slow intestinal motility. It is known that fecal transplants may be necessary to alleviate the disease.

Digestive Disease Week, 2018 from Medscape Medical News

E. New medication to treat acute Flu symptoms; updates; Reminder about Shingles vaccine

New Medication for Flu Symptoms; Updates

  The FDA just approved a new medication, baloxavir (Xofluza), to treat acute flu symptoms, for those 12 years and older. It requires one oral dose. Common side effects include diarrhea and bronchitis.

  It is similar in effectiveness to oseltavir (Tamiflu). It must be taken within 48 hours from the onset of symptoms and on average will shorten the symptoms by 24 hours (similar to Tamiflu). The drug inhibits an enzyme that is required for viral replication.

  Another study noted those who get flu shots (annually) may get an even better protection from the flu vaccine. Get the flu shot!!  JAMA, FDA News Release, October, 2018

  The 2017 flu killed 183 children and was as severe as the 2009 H1N1 flu pandemic. Despite disappointing success last year, it is still extremely important to get vaccinated to potentially prevent complications. Although the nasal spray live vaccine (Flumist) was not recommended last year for children, it is this year. For adults, the injectable form is recommended. Consultant 360, October, 2018

  Don’t forget to get the new and improved shingles vaccine (Shingrix), which is artificially produced (recombinant) and is much more effective than the old live viral vaccine (Zostavax). Shingrix is 90+% effective for all ages, whereas Zostavax was only 30% effective in older patients.

  It is much more effective in preventing the rash and the dreaded post-herpetic neuralgia, a debilitating pain (neuropathy) syndrome caused by the infection. Those 50 years of age and over should get this vaccine. The new vaccine does cause more vaccine site redness, but otherwise is well tolerated.

  25% of the population is at risk for this severe neurocutaneous viral infection caused by the Herpes Zoster virus, which can be activated by anyone who has had chicken pox as a child.

  2 doses are necessary, with the second one 2-6 months after the first. People need to get this vaccine even if they received the Zostavax vaccine in the past because of the significant extra protection one gets with the new Shingrix vaccine (90% protection). www.cdc.org

F. FDA restricts flavored e-cigarettes after youth rate of vaping doubled in a year

  FDA Commissioner Scott Gottlieb announced that there will be a ban on flavored e-cigarettes sold in convenience stores in an attempt to curtail the fast rising use of e-cigarettes by teenagers, especially since the rate of vaping in the youth has doubled in just one year. Sadly, it will not include age-restricted stores or online. The FDA plans to seek a ban on menthol cigarettes as well.

  The most popular brand (Juul e-cigarette) was targeting teenagers and had verbalized their acceptance of restricting fruit flavored e-cigarettes because the FDA threatened to ban Juul e-cigarettes. The FDA also is cracking down on verification of age 18 for age-restriced and online sites (how?).

  20% of high school students are using vaping e-cigarettes according to the CDC.

The State of Washington doubled its death rate from auto accidents due to pot smoking in just 2 years. Just sayin’…

2. Bad Actors in Big Pharma, Law, and Medicine-sad stories (stress incontinence explained)

  There are many examples of failure by the healthcare system regarding medical safety and efficacy. The stringent process for drug approval has even failed us due to unforeseen late complications. This has led to a psunami of lawsuits especially in the U.S. (90% of the lawyers in the world live in the U.S.), and it is extremely hard to test any drug or medical device in every circumstance. Medical devices (durable medical equipment) is another area of concern.  

  The medical profession is an inexact science, and there is always a clash between spending many years to approve a drug or procedure and those wanting the system to fast track clinical studies to rush the supposed miracle drug, device, or procedure to the patient. The pharmaceutical industry is a big offender as well in keeping the cost of medications extremely high.

 A. Big Pharma (Big Fraud) is Blocking Generic Companies from producing generic drugs

   Background  

  Big Pharma (Big PhRMA)--the nickname for Pharmaceutical Research and Manufacturers of America-- is getting away with blocking generic companies from producing the generic equivalent of the brand name drugs.  The brand name company is also refusing to allow samples to be analyzed to be sure their generic drug is exactly the same quality as the brand name, which is required by law. The FTC (Federal Trade Commission) is investigating it and hopefully will be stopped. There is currently bipartisan support for a bill being proposed. 

  Big Pharma and Medicare drug prices   

  The pharmaceutical industry has kept us hostage because the past few presidents and several congresses have not had the will to negotiate with Big Pharma for Medicare, because the lobbyists have our U.S. Congress (especially Republicans) in their pockets, and we still have done nothing. Perhaps having a Democratic House of Representatives will help.

  Current Administration trying to clean up the system

  In October, President Trump signed a bill to allow patients to ask the pharmacist which drug fee is lower…paying cash for a medication or having insurance pay. It was called the “gag order”, and Congress passed the bill, and signed by Trump to stop this ability for the pharmaceutical industry to keep this information from us. Published in the New York Times, April 14, 2018

B. Some law firms preying on patients with vaginal mesh implant complaints with some unscrupulous doctors—New York Times article

  Certain law firms are soliciting patients (TV and internet) that have side effects (bleeding, extrusion, pain on intercourse) from placement of a vaginal mess implant for urinary stress incontinence.

  They hired marketing companies to call these patients offering removal of the implants in Georgia and Florida providing lawsuits to sue for damages. Many were intimidated by citing potential serious life threatening complications, but who may have had better solutions for their discomfort rather removal. But the lure of monetary compensation was hard to resist.

  Most of those contacted were uninsured and offered a loan to cover the cost of flying to these states, a motel room, and the cost of the surgical removal and clinic expenses (paying a few doctors a large sum to remove the implant). Some unscrupulous banks (Germany) offered these loans at extremely high interest rates. The law firm offered to file a lawsuit and would not charge them unless they collected a settlement.

  These patients were flown to certain cities (some in Georgia and Florida), put up in a motel, and transported to a clinic where they had the implant removed under local and then sent back to the motel to be returned home the next day. Many had recurrence of stress incontinence after removal.  

  Most of the court documents cited that the recovery of money went almost totally to the lawyers, marketing company and surgical clinics and surgeons with little or no money going to the patient.

  The loan company then came after those patients to demand payment of the loan with very high interest rates and were forced into bankruptcy due to the lack of funds to cover the scam.

  Others were offered smaller upfront payments to pay for the surgical removal and when the lawsuits were successful, all the funds went to the law firm, marketing company, and bank loans.

  Most of the lawsuits regarding mesh implant complications have been properly handled and many  deserving patients have won their lawsuits. The literature notes that about 5% have serious complications that might need consideration for removal and further surgery. Other excellent studies cite 3.3% removals over a 9 year period.  

  This mesh implant has helped thousands of patients who would not have consented to major reconstructive surgery. Unfortunately many doctors inserted some of these implants without having satisfactory studies to prove its safety and effectiveness. As in any surgery, proper selection of patients is key to success.  

  There are many non-surgical options for urinary incontinence and surgical intervention should be a last resort (weight loss, Kegel pelvic exercises, yoga, etc.).   

  If a woman is having problems, they should return to the surgeon who implanted it. Studies show 1 in 15 women may need removal or partial removal over a 9 year period.

Where it all started

  A Swedish OB/Gyn doctor Ulf Ulmsten in 1998, who developed the mesh sling (transvaginal) for stress incontinence, however, he did not do adequate studies on the long term results of this procedure. He reported an 84% success rate in Sweden and Norway.

  The doctor sold the rights to Johnson and Johnson Co. in 1997 for $millions, who encouraged surgeons worldwide (reporting his results in medical journals) to perform this procedure without sufficient safety and efficacy clinical trials, and the approval was through a fast track system. When the procedures became very popular, complications started to occur, probably more because there was poor selection of patients by doctors.   

How incontinence occurs

Stress incontinence occurs when one strains, laughs, sneezes, etc., which presses the bladder against a weakened pelvic urethral suspension system, and there is urinary leakage.  

  The transvaginal insertion of this mesh implant (TVT-tension-free vaginal tape procedure) was a dream come true since the former procedure was much more invasive requiring general anesthesia and hospitalization. 3 million patients worldwide have had the procedure according to the British Medical Journal in 2018.  JAMA, Oct., 2018

Mesh implant placement

I have reported on urinary incontinence in a previous report:

www.themedicalnewsreport.com #20

  Beware of class action lawsuit ads on the internet and television!! Going out of town for procedures is often very risky unless a patient does their homework.

References--The British Medical Journal, October, 2018, and The New York Times, April 14, 2018

C. Cardiac Stem Cell research scam at Harvard’s Hospital

  Dr. Piero Aniversa, a pioneer in cardiac stem cell research was the Director of the Center of Regenerative Medicine at the Harvard University’s Brigham and Women’s Hospital  Medical Center in Boston, Massachusetts. The University is calling for the retraction of 31 journal research articles that left the prestigious medical facility in disgrace for research misconduct because of falsified and fabricated studies to obtain federal funds.

  He suggested that a subset of cardiac stem cells could regenerate heart tissue in patients with heart failure. Independent studies have not substantiated his claims and have created an international incident in the field of stem cell research.

  There has been well substantiated value of stem cell transplants in treating certain blood cancers, however, there are clinics all over the U.S. using stem cells to treat everything from eye to orthopedic disease without solid research to prove their value without harm. Research is, however, ongoing in various fields of medicine to prove or disprove their value.    Medscape, Oct. 2018   

3. End of Life Issues--Physician assisted suicide; Palliative and hospice care as an alternative

      Dr. Kevorkian

One quarter of Medicare spending occurs in the last year of life. Patients with multiple chronic diseases spend close to $57,000 per year on health care.

  Predicting when patients are going to die is very difficult, and doctors should be very careful predicting longevity. Hearing a patient has 6 months to live creates stress in patients and families, and yet, they need to know time may be limited. It is felt by some in medicine that end of life care could improve and perhaps prevent thoughts of suicide and despair.

Palliative and Hospice Care

  Patients and families must consider the helping hand of palliative care and hospice services earlier and consider this as a good way to deal with end of life. The issue of a patient ending their life when faced with a terminal disease, severe pain, or severe impairment from a disability is a difficult one and one that has been discussed for years.

  There are some states (Colorado, Washington, Vermont, California, Oregon, Montana, Hawaii, and Washington D.C.) that have passed laws to allow physicians to write prescriptions for patients to end their life, the definition of physician-assisted suicide and there is not a lot of sources to reach out to. This is in contrast to the Dr. Kevokian method of euthanasia, where the physician is authorized to give medication to end life.   

  Some of the reasons patients consider suicide include a patient with decreasing ability to participate in activities that make a person’s life worth living (quality of life), severe pain, disability, loss of being independent, and loss of dignity and hope.

  End of life issues are even harder on those who have lost their spouse and are alone. I have heard many say that they would never go to a nursing home, however, education, knowledge, patience and understanding is needed to work through such considerations. It is extremely distressing to watch a loved one suffer, and I am sure many lives end without anyone really questioning how they died.

  Knowing one is going suffer slowly over time would make some consider ending their life, but most have support from family and friends to steer away from thoughts of suicide. However, there are effective alternatives to physician assisted suicide that certainly should be strongly considered such as palliative care services and hospice. These services should not be limited to the last few weeks of life. Both medical personnel and families must understand this a proactive move to provide quality care to the end of life.

  Palliative care is poorly understood and deserves consultation with an expert. Palliative and hospice care work hand in hand and provide valuable support to both patient and family. For those who are members of churches and have religious support, they must be included with palliative and hospice care. 

The team approach for palliative care

  I have addressed palliative care and hospice in a previous report www.themedicalnewsreport.com/52/61

  The palliative care team at minimum includes a palliative care physician, specialized nurse, and social worker. This specialty is a multidiscipline approach to specialized care for those with serious illness addressing pain, physical, psychological, and social stresses of a terminal or debilitating illness.

  Palliative care physicians consult with social workers, counselors, support groups, rehabilitation and occupational therapists, along with the patient’s personal physicians. Family issues are addressed as well as financial stress from the cost of treating an illness.

  In the end, the primary goal is to improve and maintain quality of life to the very end. These experts need to be consulted long before the illness seems hopeless. This has been a challenge because of the false perception that physicians, patients, and families are giving up……and that is false!! This move should be seen as an empowering decision.

  Currently there are 1400 palliative care programs in the U.S.

  Ethical issues, pros and cons need to be considered:

1. Pro-The right to die should be a fundamental freedom of every human---Con-A desire to die is a cry for help!

2. Pro-Patients should be able to die with dignity rather than experience an excruciating endng to their life---Con-Suicidal intent is frequently transient in a moment of despair.

3. Pro-In a time when 80% of the Medicare dollar is spent in the last year of life, the cost of those whose life is going to end soon has got to be considered---Con-Those who are suicidal are usually depressed and can be treated in most cases.

4. Pro-Enduring severe pain and distress from a terminal illness is unnecessary---Con-Pain is controllable in most cases with expert professional help.

5. Pro-Death is a part of the life cycle---Con-Serious consideration for legal routes can be considered, however, there are alternative ways to die with dignity using palliative and hospice care.

6. Pro-Assisted suicide will prevent prolonging the family’s pain---Con-Patients have the sole right to make decisions about do-not-rescuscitate (DNR) or can provide a power of attorney to make decisions for the patient’s wishes including pursuing assisted suicide. Mercy killing is a crime.

7. Pro-Physicians are in the profession to help people which should include assisted suicide---Con-Physicians are not trained to perform assisted suicide and should turn to palliative and hospice care.

Personal comment—Since I was in private practice for 30 years, a significant part of my practice included head and neck cancer surgery and I had to witness some of these patients dying from recurrent disease or disease that did not respond to standard therapy. We had a wonderful palliative and hospice care facility for these patients. I never saw a patient not able to be kept comfortable to the end, even if they had to be given enough sedation and pain medication to be unconscious. With their permission, we can stop food and hydration, and it did not take long for nature to take its course.

  The debate will go on regardless how the states regulate assisted suicide. While patients suffer in every way, a complete evaluation both physically and psychologically must be made to see if there is any hope for improvement with medication and other supportive treatments. Consultation with experts in the field regarding palliative care and end of life care will give the patient and family assurance that all avenues will have been explored.

  Oregon was one of the first states to allow the right to die laws. Here are the rules to qualify in Oregon below:

We all have strong feelings about veterinarian euthanasia, but when it comes to humans, the decision is much more complicated.

To date, there has been no Supreme court decision (such as Roe versus Wade) defining the right to die, but states have addressed this.

  Religious organizations certainly have strong opinions on this although Buddhists allow it.

  We would all have to search our souls to decide what we would do in a circumstance such as those who face quadriplegia, ALS, terminal cancer, disabling heart disease and post-stroke paralysis, etc. Discussing this with family is a good idea long before these issues are facing them and be sure you have legal documentation (DNR) for directives on ending or prolongation of life.

  I refer you to www.deathwithdignity.org to create an advanced directive and appointing a health care proxy (power of attorney). If you have one, review it and make sure you agree with it today and keep it up to date!!

www.assistedsuicide.org  

WebMD; Wikipedia

4. Attempting to decrease drug costs

    A. President Trump working on Medicare drug costs—negotiations for Part B and D

     B. Buying medications outside the U.S.

     C. Discount medication websites

     D. Biosimilar medications

A. Trump Administration working on Medicare drug costs—Part B and D

  Big Pharma made over a $trillion dollars in 2014, but have a history of fraud, bribery, lawsuits, and fines in the billions, and that cost is passed on to the public.

  Big Pharma is the biggest defrauder of the federal government according to consumer watchdog group, Public Citizen.

  Pfizer Pharmaceuticals made the most revenue in 2017-$52.5 billion. By 2021, Big Pharma profits for prescription drugs are expected to reach $610 billion and $457 billion on medical devices. That is not to say, companies should not be able to make as much money as possible, but it should not be at the expense of the American public by manipulating our U.S. Congress with legal donations to prevent our citizens from being financially destroyed paying for medications.

  Americans spent an all time high of $457 billion on prescription drugs in 2015 and rise by billions each year. Drug prices are rising 11-12% per year while the American worker’s wages are rising 2.5% annually according to www.drugwatch.com  

  For every $1 spent on basic research by Big Pharma, they spend $19 on promotion and advertising. They have 1,378 paid lobbyists on U.S. Capitol Hill.

  The president and his administration are attempting to attack the cost of medications from various angles, and now the big savers are being addressed—Part B and D Medicare drug plans.

International prices

  The Trump administration is working on negotiating with Big Pharma to pay no more than the lowest prices than other countries pay for Part B medications and durable medical equipment and Part D drug plans. This may become even more of a reality now that there is some balance of power in the U.S. Congress.

  Medicare Part B drug costs rose to $28 billion in 2016 primarily because of cancer and rheumatology drugs  administered by doctors. This negotiation for changes in Part B Medicare drugs and durable medical equipment would save $17.2 billion over 5 years according to HHS.

  (Most medications are covered under Part D drug plan and President Trump will attempt to negotiate those prices as well).

  Drugs covered by Part B Medicare are those which a patient would administer to themselves such as bronchodilators in breathing machines (nebulizers), injectible medications, agents to stimulate the blood system, blood clotting factors, nutritional IV products, vaccinations, transplant drugs, oral cancer meds, dialysis meds, and drugs administered in an outpatient medical facility such as cancer drugs.

  Durable medical equipment covered by Part B Medicare would include blood sugar monitors, canes, crutches, hospital beds, wheel chairs,  commodes, continuous motion machines after total knee replacement, oxygen equipment, CPAP machines for sleep apnea, traction equipment, suction machines, and more.

  Part D Drug Plan covers all other medications primarily those patients take at home.

  There are 6 protected classes of drugs now covered by Part B that could be moved to Part D (antidepressants, anti-psychotics, immunosupressants, anti-epilepsy drugs, antivirals for HIV, and cancer drugs). Secretary of Health and Human Resources, Alex Azar, sees no reason why these Part B drugs and durable medical equipment could not be covered under Part D, and which could save billions, according to Azar. Hopefully that will be addressed.

Other places to save healthcare costs

  a) Distribution Centers; Pharmacy Benefit Managers

  The drug manufacturers have a middle man industry that stores and distributes medication before the drugs are distributed to pharmacies called Distribution Centers. They charge millions for their centers, and they have way too much power.

  They control rebates and discounts for drugs which should be going to the patient but many times are not. This has raised costs greatly, and now Walgreens and CVS are buying some of these distribution companies (bad news). I have reported on this issue (drug costs and pharmacy benefit managers previously:

www.themedicalnewsreport.com/69

  Because of this chess game, the drug makers raise their prices to maintain their profits and offer bigger rebates as a way to compete with other drug companies who have similar drugs. That would be ok if the rebates were going directly to patients, but they are not. There is now finger pointing between the drug companies and the pharmacy benefit managers since President Trump is coming after the rebates. Mr. Azar is trying to going after the “safe harbor” rule that prevents rebates from being a kickback to drug companies.

  b) Big Pharma paying off generic drug companies—another place Trump must attack   

    I have previously reported that brand name pharmaceutical companies have been caught paying off generic companies to delay manufacturing drugs that have gone off patent. This allows the brand name company to enjoy high prices even though the drug is no longer protected by patent. These companies have had large fines, but it is a slap on the hand compared to the profits from certain drugs. When are the CEOs going to jail? This must be addressed by the Trump administration and stop this wholesale fraudulent practice.  

B. Buying medications outside the U.S.

  Currently, it is technically illegal to buy medications from outside the U.S. including Canada. And yet, there are Canadian pharmacies open all over Florida (and other states), who are happy to sell you medications. The prices are considerably less, but insurance does not pay for them.

  Before buying drugs out of country, compare them with discount websites—Good RX, the Link, etc.). Patients also must consider copays, deductibles, and hitting the donut hole in Medicare in comparing drugs bought in either of these alternatives routes.

  Canada and most countries negotiate prices with Big Pharma as most countries with socialized medicine. Prices can be as much as 55% less expensive than the same drug in the U.S. There are currently bills before Congress to allow Canadian drugs legally. (Dorgan-Snow Drug Importation bill).

  Even though federally illegal, Wisconsin, Illinois, Minnesota, Vermont, and many city governments have either approved the practice or turn their back on the illegality.

  Many doctors are willing to assist patients purchase medications outside the U.S. Ask yours!!

  Drug companies have deep discount programs for needy patients.    

C. Discount medication websites

  There are now discount companies that only require a person to subscribe or get the app for free. Two of the most popular websites are Blink Health and GoodRX. Discount cards are easily available. Drug prices vary widely from pharmacy to pharmacy and even pharmacy locations, and these websites will find the lowest price for you. CVS and Walgreens are two of highest. WalMart is lower in most cases, but they vary depending on the drug. These websites can find the best price and provide a patient with coupons (discounts as high as 75%). Check it out:

www.goodrx.com/  www.blinkhealth.com/

 D. Biosimilar Medications can save money

  Congress, through the Biologic Price Competition and Innovation Act of 2009, created an abbreviated licensure pathway for biological products that have been  demonstrated to be similar biologically to current FDA approved medication and can be used interchangeably. This pathway was created to allow more treatment options, increase access to lifesaving medications, and save 20-30% of the cost of production.

  Biologics have become very popular for serious illnesses including Humira for rheumatoid arthritis, Herceptin for breast cancer, and Neupogen for white cell destruction secondary to cancer drugs and these drugs can cost $50,000 a year.

  Biologics are often proteins derived from plants, animals, and even humans to control the action of other proteins causing disease. There are various ways they function:

1) Manipulate genes that control vital production of proteins in cancer cells

2) Modified human hormones

3) Cells that produce substances that suppress or activate certain aspects of the immune system.

  Biologics are used to treat autoimmune disease (ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, lupus, etc.), diabetes, multiple sclerosis, asthma, and many other diseases. Because of the expense of these medications, it makes sense for pharmaceutical companies to create biosimilar drugs.        

 WebMD, www.fda.gov

5. Antidepressants—difficult issues

  A. Stopping antidepressants is difficult

  There are over 15.5 million Americans that have been taking anti-depressants for over 5 years. The rate has almost doubled since 2010, and more than tripled since 2000. Nearly 25 million Americans have been on antidepressants for at least 2 years. In 2013, 34.5 million Americans were taking anti-depressants. White women over 45 years of age account for 45% of the users, however, more older women are now taking the medications than ever before.

  Anti-depressants were never meant to be taken for years. It was intended to treat episodes of depression and anxiety, but since the results were gratifying for many patients, physicians and patients chose not to stop them. Many patients would never consider stopping their anti-depressants because they felt so much better. For those who decided to stop, they found an enormous stumbling block to get off these medications—withdrawal!

  Many doctors did not realize how difficult it is to stop these meds. Withdrawal causes feelings of anxiety, dizziness, confusion, and fatigue (“brain fog”). For many stopping these meds was not that difficult, however, for those who found it too difficult to stop, often restarted.

  Many medications stop working after a period of time and a different antidepressant must be prescribed or the dose raised.

  As usual, pharmaceutical companies never concentrated on the effects of stopping their medications, and there has been little research on the withdrawal effects of stopping antidepressants.

  Side effects of taking antidepressants are not necessarily mild including loss of libido, impotence, emotional numbing, and weight gain.

  Most of the modern day anti-depressants maintain higher levels of serotonin in the brain, a critical neuroreceptor transmitter, and stopping these medications will decrease serotonin levels creating side effects.    

  It may take as long as a year to stop antidepressants. As many as a half of patients have been unsuccessful in tapering off the medications. In one study, over half of the patients stopping these meds found it extremely difficult. This is an important issue to discuss with the treating physician regarding the plan of stopping antidepressants.

  B. Drug resistant depression; Genetic testing to determine the optimum antidepressant to prescribe

  Scope of depression

  Depression is a major problem for millions of Americans, and one of the major stumbling blocks in treating major depression is finding the best antidepressant that works. Only about 50% of patients are relieved of their depression using the best antidepressants (SSRI/SNRI)* the first time. Sometimes, a second medication may be necessary to add.

*(SSRI/SNRI)Selective serotonin receptor inhibitors and serotonin/norepinephrine receptor inhibitors—These are neuroreceptor chemicals that determine mood among other functions.

  I have reported on depression and anti-depressants in several reports, but the most recent are: 

          www.themedicalnewsreport.com #36 ,and Medical Report #50

Drug resistant depression—needing a second antidepressant

  Antidreppants usually require 6-8 weeks to be fully effective!! However, close to 50% of patients do not adequately to the first antidepressant prescribed. Sometimes, either because of side effects* or not responding, patients go without treatment and suffer the consequences. Doses often must increased as well.

* side effects of antidepressants can include nausea, weight gain, loss of sex drive, tiredness, difficulty sleeping, dry mouth, constipation, blurred vision, dizziness, and anxiety

  The FDA has just approved the first antidepressant for drug resistant depression—Symbyax, a combination of Zyprexa and Prozac

  There are add-on antidepressants, and the most common are Abilify, Seroquel, and Zyprexa. This should be discussed with the prescribing physician. Counseling must often be added as well.

  For extremely resistant patients, ECT (electroshock therapy) may be used effectively. Transcranial magnetic electrical stimulation has also been used as well as electrical stimulation of the vagus nerve (VNS) in the neck with a pacemaker placed under the skin.

Genetic testing to determine the best antidepressant

  Genetic testing for disease potential and guidance for treatment continues to expand. Please understand and only applies to less than 10% of cases. It is still a young field and although expanding, it has a long way to go. Be careful about slick ads on TV.  

  This study is the first (admittedly supported by the drug company that sells it) to report that using DNA testing can help determine genetically which is the best treatment. The test is called GeneSight, which requires a swab of saliva. This was presented at the annual American Psychiatric Association 2018 meeting. It was intentionally used on those who had not been successful with their first anti-depressant.

  This study found that treatment resistant patients responded 30% better and 50% more achieved remission of their depression when their antidepressant was selected based on the GeneSight test involving 12 genes and 56 medications. These results were determined after 8 weeks of treatment. Results are returned to the doctor in 36 hours.     

  It would be a real breakthrough if this genetic test to guide therapy pans out long term. This is being used at several major medical centers and in some cases being used to determine the first drug to use from the beginning of diagnosis. It is also helpful to determine if more than one medication is necessary and that these two medications are in sync with each genetically.

  Although this testing is not considered the standard of care currently, hopefully as more cases are tested and longer term results are obtained, it will find its place in treating major depression. It certainly will be a sea change for treating a difficult psychiatric illness. 

Medscape, May, 2018    

  C. Antidepressants and weight gain

  A study cited in the UK that anti-depressants are being prescribed to 18% of British people (300,000 Brits). The average weight gain was 5% of body weight.

  In other studies, at least 25% of those prescribed anti-depressants gained 10 lbs. or more (especially SSRIs—Paxil, Lexapro, and Prozac, etc.). However, other classes of antidepressants such as the MAO-inhibitors (Parnate and Nardil) and the Tricyclics (Elavil, Tofranil) can also cause weight gain. Weight gain is more likely after taking them for 6 months or more.

  WebMD stated that patients experience increased appetite, and a craving for carbohydrates. When patients who are depressed, their appetite is diminished in many patients, and when the depression is lifted, patients feel better and tend to have better appetites.

  Between appetite stimulation and decreased metabolism, weight gain can occur unless patients adjust their life style to counter this unfortunate side effect. Increase exercise and reduction of calories can counter this in most patients. Daily exercise is also a known factor in treating depression.

  Wellbutrin is one of the few that can cause weight loss, and the 2 SSRIs (Effexor and Serzone) are least likely to cause weight gain whereas Paxil is the worst. Zoloft is also less likely to cause weight gain.

  The Cleveland Clinic states that adding a small dose of Wellbutrin to other anti-depressants may prevent weight gain. Another drug, naltrexone, which reduces the euphoria of opioids and alcohol, has been found to assist in preventing weight gain.

  Physicians must monitor how patients are doing and be ready to adjust dosage, add a second drug, or switch drugs to obtain better results including the weight issue. Patients should be very careful to take weight loss medications (including herbal supplements) to counter the anti-depressants.

  This issue has kept depressed patients (especially women) from taking proper medication and needs to be addressed by the treating physician. It is important to contact patients and make sure they are still on their medication.

WebMD, Cleveland Clinic     

  This completes the December report. A new year is just around the corner. The January report will include:

1) The Broken Heart Syndrome

2) Sexual issues resulting from medical conditions and treatment

3) Central Sensitivity Syndrome—New name for syndromes including Fibromyalgia and Chronic Fatigue Syndrome

4) Essential Tremors—what do they mean?

5) Uterine Diseases—Part 1--Uterine and Cervical Cancer

6) Cancer Survivorship Series--#3—cancer pain; financial pain  

 Have a wonderful December and  Holiday, and a very Merry Christmas, Happy Hanukkah, and other religious holidays! As always, stay healthy and well, my friends, Dr. Sam