The Medical News

Report

#138    

   July, 2023

Dr. Samuel J. LaMonte, M.D., FACS

samlamonte@gmail.com

www.themedicalnewsreport.com

Subjects for July, 2023:

1. Late breaking Medical News-Prior authorization insurance policies bad for patients and medicine; New drugs for Alzheimer’s; Will Medicare drug prices drop in 2025?; The next COVID vaccine booster-components; new CDC Director

2. Breast Cancer Series--Part 1— 2023; diagnosis, treatment, and more

3. Celebrities with unusual medical conditions—Justin Beiber, George Clooney, Senator Feinstein--Facial palsy, Shingles—Ramsey Hunt Syndrome;

Lady Gaga-Fibromyalgia

4. A possible alternative to Statins—Bempedoic acid

5. Hepatitis A, B, C; Complications of cirrhosis

6. New drug that can enhance libido, sexual arousal—Kisspeptin; Also a new topical gel to improve sexual experience--Eroxon

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, as it is becoming challenging.

  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 of therapy 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. Never stop one without notifying the doctor.

  The more you know about your health, 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, and accompany those who need it.

Thank you, Dr. Sam

1. Late Breaking Medical News

  a. Prior authorization for colonoscopy and other medical issues—big trouble

  b. New drugs for Alzheimer’s Disease

  c. Will Medicare drugs drop in price in 2025?

  d. The next COVID vaccine booster for this fall-components?

  e. Biden picks the next CDC Director, after Dr. Walensky resigned

a. Prior authorization big trouble

  I am undergoing a series of surgeries for an infected shoulder implant, and needed two different medications that, as of this year, require prior authorization for insurance to cover them, which took a week of communications from my pharmacy, my doctors, and insurance company. I finally got cooperation and the issue was resolved, but a recent article regarding prior authorizations for insurance coverage, some of which now will require additional paper work from the doctor to the insurance company to have the procedure, medication etc. covered, will delay procedures and medications.

  This added paperwork is essentially saying that the insurance company does not believe the doctor has taken enough time to assure the patient and the insurance company he or she really needs the drug or procedure. Ultimately, this is slowing the process, delaying payment for these medical issues to doctors and hospitals. The incident in the article was regarding prior authorization for colonoscopy.

  Often, colonoscopy and diagnostic procedures are urgent and this piece of federal legislation is going to delay medical treatment. This clearly is an attempt by Big Medicine, Big Insurance, etc. to save money. This is just the tip of the iceberg when socialized medicine tries to take over, because it is all about cost containment, and socialized medicine is the poster child for this.

  Prior authorization is just one more step for physicians who are swamped in paperwork. This started in the 80s, when managed care began, and essentially said doctors were performing too many procedures and needed to be more strictly questioned regarding the indications for the procedure(s). In some cases, it is true, but, as usual, a few bad eggs spoil it for the majority of good hard working, ethical physicians.

  When I was in my surgical practice, I had many surgeries cancelled the day before surgery by the insurance companies wanting “just one piece of paper filled out”,, which made me lose a procedure temporarily, having to re-schedule it, upsetting the patient and their schedule, etc. It has escalated since then, and with HMOs and Medicare Advantage, it has gotten out of control, and the Congress is stepping in to address the abuse (I doubt they will be successful in improving anything).

  This is new information, so don’t be surprised when this issue arises with you.  Since I first started writing about this issue, it has happened to me again about a necessary dermatologic medication.

  Don’t wait til a medication, test, or procedure becomes an emergency to see about it. Stay close to your primary care doctors and work with them, and try to stay ahead of this game the insurance company is pulling.

   It is the feds, the insurance companies, and Big Medicine trying to make practicing medicine and more difficult every day. This is one of the main reasons doctors retire early, and it has created a shortage of doctors (and nurses), and made a lot of American youngsters turning away from medicine.  Medpage Today, May 24, 2023

 b. New drugs for Alzheimer’s (AD) encouraging

2 drugs have been FDA approved by their advisory committee (the FDA still has to give final approval) for AD.

  The FDA Advisory committee unanimously approved lecanemab (Leqembi) paving the way for the traditional approval of the new drug after phase 3 of clinical trials, the last phase, is reviewed by the board of directors.

   The IV infusion of this drug targets amyloid beta, a protein that abnormally infiltrates parts of the brain in AD (the other protein is tau, which form tangles around brain cells). This drug slows the cognitive decline in AD.

   The multicenter double blind study (by the drug company Eisai, Inc.) of 1795 patients who had mild cognitive dementia with AD. There was a 27% decrease in cognitive decline as measured by testing 14 tasks.

   37% of functioning was better in the group that received the drug, compared to the placebo group. It was estimated to delay cognitive decline by an average of 5 months giving them more time to live independently, enjoy more activities, hobbies, and interests.

It will still require follow up studies for safety and continued effectiveness of the drug. With unanimous approval, it will not be long before the drug will be available. There have been many drug failures trying to slow down the progression of dementia in Alzheimer’s disease to no avail.  But in this case, unanimous FDA advisor panel approval means likely full approval by the FDA for marketing the drug.

Medscape, June 12, 2023   

A drug for control of agitation and hallucinations

  Brexpiprazole (Rexulti), a drug on the market for failures in those with depression, who need a second drug, primarily to control agitation and hallucinations. Now the FDA has approved it officially for those with AD who deal with agitation. We will see if it helps after some more data with some time. Dizziness and lightheadedness is a concern as a side effect, and therefore, getting up from the bed or a chair will need to be careful.

c. Will Medicare drug prices drop in 2025?

  The Inflation Reduction Act (aca Climate Change Act) of 2022 includes several initiatives aimed at reducing out of pocket drug costs for Medicare recipients, such as gradually abolishing co-insurance for catastrophic coverage eventually capping annual out-of-pocket drug costs at $2000 by 2025.

  The investigators of these claims analyzed the cost reduction of 4 cardiovascular conditions usually requiring high cost guideline recommended medications (severe elevated cholesterol, heart failure, atrial fibrillation, and cardiac amyloidosis). They estimated the reduction in out- of-pocket costs by 8 to 87%. The explanation was vague, and the range of cost savings was very wide.

  They also did not explain how the federal costs would be covered, but so far, it appears to come from increased taxes.

  These kind of articles are appearing in the medical journals with no explanation of research techniques. It is apparent, as in many left leaning medical journal articles these days, that until we see actual reductions, their conclusions should be taken with a “grain of salt”, since this has been tried before. Trump tried to reduce these costs with no result, and except for 2 companies that agreed to reduce insulin to $35 a month out- of- packet costs, there has been nothing but large increases in drug prices across the board.

  As long as Big Pharma has significant influence on the Congress, who passed a law to allow no negotiation in Medicare drug prices (to get negotiated Medicaid prices), we are seeing these lollipop benefits thrown at doctors trying to devert attention from the $trillions of dollars being spent on climate change issues (none of which are even in the top 5 most important concerns in this country, reimbursing those willing to spend big bucks on their list of climate related issues from electric cars, to massive regulations in environment.

  I hope that cost saving can occur, but in this atmosphere of inflationary expenses, high cost of food, supplies, high housing mortgages, overrun borders, drug crises, human trafficking, etc., call me a skeptic.

NEJM Journal Watch, May 30, 2023   

d. The next COVID-19 vaccine booster-components?

  The next booster should be composed of the more recent Omicron variant soley—XBB.1.5, according to the FDA advisory panel, which will be available this fall.

  All 21 members of the panel recommended not to include the original Wuhan strains in the vaccine we faced early in the pandemic. This makes the booster a monovalent vaccine and distinctly different than the ones available.

  The current vaccine is losing its efficacy against the  strains today causing illness, which accounts for 95% of COVID cases worldwide. This vaccine will be available from Pfizer, Moderna, and Novavax, all who have targeted XBB.1.5, which is responsible for 40% of the current cases.

  There are 2 newer strains XBB.1.16 and 2.3, which represent 25% of the new cases, but the FDA panel doesn’t intend to include them, at least for now. That could change before the fall booster is produced and marketed. They say the proposed booster will have good cross reactivity with newer variants, but we have heard that before too.

  The current bivalent booster has been very unpopular (only 16% of the population) and actually is turning out to be less effective than hoped. Why do they think the next booster will be any more popular with the public than the flu vaccine, which has been pretty effective this year.

  This booster creates an activation of immunity from the B cell lymphocytes, but it should be remembered that T- cell immunity will continue to be active, so we have some protection from COVID regardless of the variant. Also, herd immunity is another protective factor.

  The FDA does not have to go along with the advisory panel, but often does, and it is rare to see 100% agreement from the FDA advisory panel of experts and not expect the FDA to give final approval.

e. Biden picks next CDC Director

President Biden picked the top North Carolina health official, Mandy Cohen, M.D., MPH. She is another public health official, who has been highly involved in the management of the pandemic in her state. She was the Secretary of North Carolina’s Department of Health and Human Services.

  The CDC has a $10.7 billion budget, which was passed in December. She will be the administrative head having to deal with the current administration and they still have too much power over the runnings of the CDC, in my opinion. BTW, Dr. Wallensky, who recently resigned, gave no good reason for checking out. I suspect she will open up with the reality of the problems of the administration and its over-influence of the CDC, as Dr. Redfield did after he left (before Dr. Wallensky).

The Republican House of Representatives for North Carolina, Ted Budd and Dan Bishop, who took issue with her handling of the pandemic. They feel she has too much politicized science, disregarded civil liberties, and spread misinformation about the value of the vaccine, and has a history of engaging in partisan left wing politics. Sounds like we will just get another “yes-man” as the leader of the CDC. Until the CDC is an independent organization, it will never be able to provide non-political decisions, sticking solely to proven scientific data.

Medpage Today, June 19, 2023

2.  Breast Cancer Series-Part 1—new information, testing, types of cancer

  A. Introduction

Breast cancer is a huge subject and will require a few monthly reports to provide the most up to date information. When you click on my website subjects index (home page), you will find many reports on most of the critical issues in diagnosing and treating breast cancer. Much of the information comes from The American Cancer Society (40 years of volunteering), which is quite extensive. www.cancer.org

  It is the most common cancer women are diagnosed with (exception-skin cancer), accounting for 30% of all women’s cancers. 1 out of 8 women will be diagnosed with it in their lifetime.

297,790 new cases of invasive breast cancer will be diagnosed in 2023, according to the American Cancer Society. Also 55,720 ductal carcinomas (DCIS) will be diagnosed this year. Some call it precancerous, but that is up for discussion.

  43,700 women will die of breast cancer in 2023, often because they were not having routine breast screenings (mammograms).

  This is the second leading cause of cancer death in women (lung cancer and cardiac disease are more common). There is, however, a 5 year survival rate of 91% in women, and even higher if diagnosed as a cancer only seen by imaging.

  It occurs in middle age and older women—median age 62. A small number of women under age 45 will be diagnosed, especially those with a family history and or genetic markers such as BRCA 1 and 2 gene mutations.

  Breast cancer is increasing at a rate of 0.5% per year. However, with better diagnostics and treatment, the death rate has decreased steadily since 1989 for an overall decline of 43% through 2020, primarily due to early screening, pointing the finger at mammography as a critical tool. Add better treatments, and some would begin to consider breast cancer a chronic disease, because extending the life span of those with metastatic breast cancer can keep it controlled for years.

  Black women have a higher rate of breast cancer (1 in 5), primarily because of an increase rate of triple negative breast cancer, which will be explained later in this report.

  B. Anatomy of the breast

The breast contains a nipple, duct opening through the ducts to the cells glands that make milk (lactiferous cells), connective tissue to support the position of the breast, fatty tissue, chest muscles behind the breast, and ribs.

  The breast tissue extends into the armpit in many women, and there are many lymph nodes that drain the lymph fluid into them from breast tissue, and are the first place a cancer can spread out of the breast tissue.

  Note there is lymph node drainage above and to the middle of the chest as well (see drawing below), and when radiation is used those nodes are treated, as they are in a simple or total mastectomy.

C. Where does cancer start in the breast?

  There is a chance for cancer and other diseases to occur in any part of the anatomy.

  Nipple (Areola)--Paget’s disease,

  Ducts--tube to the lobule-ductal carcinoma and pre-cancer-in situ

  Lobule (milk ducts),

  Blood vessels-angiocarcinoma,

  Lymph vessels-lymphoma

  Fat and connective tissue-phylloides tumor.

D. Diagnosis of breast cancer—mammography, ultrasound, MRI, needle biopsy

  Digital mammography is the best for screening breast cancer. These are 3-D mammograms, compared to 2-D standard mammograms, and decrease the liklihood of being called back for more X-rays. 3-D digital mammograms  are becoming more commonly used. The added cost may not be covered by insurance.

  The FDA recently changed regulations for mammography in women with dense breasts, and are required to notify them that they are at an increased risk for cancer. The report is required to include an assessment of breast density to provide greater detail on the potential limitations of the results, and allow decisions be made to use further imaging tests to better assess the dense breast. Medscape, March 9, 2023

  The USPSTF* has finally caught up with organizations such as the American Cancer Society in recommending screening mammography to begin at age 40. This is for healthy women who do not have risk factors above the normal population. Previously the federal administration’s advisory committee recommended age 50, but recent data showing younger women are getting breast cancer now recommend starting at age 40 and have it performed every 2 years between 40-70, which still differs from the ACS.

*USPSTF=United States Preventative Services Task Force  

  Ultrasounds are often recommended if there is a question about the mammogram.

  MRIs are also recommended in women with dense breasts and those with higher risk.

Needle biopsy

Early breast cancer digital mammogram

Ultrasound and breast cancer

MRI with cancer

Calcifications on mammograms and MRIs can allow better visualization of a suspected cancer.

  The latest American Cancer Society guidelines for routine breast screening (note this is not new for the ACS, whereas the USPSTF just changed their recommendations to better coincide with ACS.

As always, a discussion with a woman’s doctor should begin no later than age 40 regarding breast screening.

Clinical breast exams are not recommended as a screening technique for average risk women at any age. However, a woman should become very familiar with the way their breasts feel and do regular checks to note changes that might need evaluation.

  E. What does a breast cancer feel like?

  By the time a lump in the breast is found, if cancer, it has advanced. Lumps in the breast cannot be differentiated between benign and malignant.

  Women have irregular breast tissue, and it changes with the menstrual period. There are many lumps or firmness in a particular part of the breast (fibrocystic disease) that is often benign and influenced by the menstrual cycle, but they must be tested if found. These irregularities in breast tissue can feel like a lump or a rope-like feel.

  Cysts and solid benign tumors (adenomas), some from inflammation and sclerosis, all can occur. They do increase the risk of breast cancer.

  Up to half of women have these benign lumps.

  There are many signs that need evaluation. There can be pain, nipple discharge, changes in the size, shape, or contour of the breast. The nipple can be inverted or scaly and the breast may have dimples. These can be worse during pregnancy since they are hormonally sensitive. Birth control pills may aggravate these benign lesions. But they must evaluated and followed since breast cancer can be present in addition to these benign lesions. Regular checkups are a must.

Cleveland Clinic

  F. Higher risk women for developing breast cancer

  Women at high risk (lifetime risk of 20-25%) should get an MRI and a mammogram yearly, starting at age 30. Those high risk women are:

a) those with a significant family history or genetic mutations (BRCA 1 or 2 based on genetic testing), those who have both a first degree family member (sister)

b) a parent, or child with genetic mutations,

c) those who had radiation therapy between 10-30 years of age,

d) a familial genetic disease (Li-Fraumeni syndrome, Cowden syndrome, or Bannayan-Riley-Ruvalcaba syndrome)

e) recent evidence considers women with dense breasts at higher risk, and should discuss having a mammogram and ultrasound or even an MRI, and the FDA requires notification of the woman, as stated above.

  The ACS states there is not enough data to recommend a yearly MRI for women with a history of ductal carcinoma in situ (DCIS), lobular carcinoma in situ, and other cases with precancerous or suspicious breast biopsies without true cancer (atypical ductal or lobular hyperplasia, or extremely dense breasts. Discuss this with a doctor.

  MRIs are used in addition to mammography not instead in higher risk women.

  Genetic counseling regarding BRCA gene mutations for prophylactic mastectomy and or ovary and tube removal, is a serious discussion, since the risk is high (45-85%) and 10-46% risk of developing ovarian cancer (there is a 12% risk for the average woman). There are many rare genetic mutations, which can be researched.

  Consideration for prophylactic mastectomy with reconstruction and removal of the ovaries and tubes is a huge decision, and families must discuss this issue with at least one or two doctors and family members before having the breasts and or ovaries and tubes removed. We are most familiar with Anjolie Jolie’s decision to do so, bur hundreds of women are choosing this option.

  Life-style risks include excessive alcohol (more than one drink a day for women), being overweight or obese especially if they gain that weight after menopause. Being inactive increases the risk, and not having children. Not breast feeding has a slightly higher risk, and birth control, even hormone releasing IUDs.

  The use of combined estrogen and progesterone (to prevent uterine cancer) after menopause (for more than 4 years) increases the risk, but postmenopausal symptoms may be severe enough to consider taking them. If a woman has a hysterectomy, she only needs to take estrogen, but the risk is there.

  Women with breast implants have a slightly higher risk of standard breast cancer, and a very rare chance of developing a special type of lymphoma forming in the scar tissue of the implant.

The American Cancer Society www.cancer.org

   G. Sentinel node evaluation for spread to lymph nodes

  Lymph nodes in the axilla are often the first place a breast cancer can spread, even early. To evaluate those nodes for possible spread, using an injection of dye near the cancer will, over a few hours, circulate to the lymph nodes via lymph vessels, and the first node it appears in, is called the sentinel node, and the node to biopsy. The blue dye can be seen in the node to guide the surgeon. If positive, lymph node removal will be necessary when the breast cancer is removed.

H. Types of breast cancer

  Cancer can be local or spread. Most are called adenocarcinoma, which start in the ducts (tubes from nipple to milk glands) or lobular (milk glands).

1--Ductal or ductal carcinoma in situ

In situ cancer is a precancerous condition that can progress to invasive cancer. It begins in the milk ducts but has not progressed to the rest of the breast tissue or milk glands (lobules). It is also called ductal carcinoma in situ or DCIS) ot lobular carcinoma in situ (LCIS). When the cancer grows, it becomes invasive and can spread to other parts of the breast and or the lymph nodes.

2--Invasive ductal or lobular breast cancer

  The ductal and lobular carcinomas can be invasive and spread to the areas of the breast, even to other breast, and lymph nodes. Spread of any breast cancer can also go to the brain, lungs, liver, and bones (the most common site of spread). Invasive carcinomas account for 70-80% of breast cancers, and

3--Hormone and protein receptors in the cancer

  Breast cancer cells can have special hormonal receptors

     -estrogen-ER and progesterone-PR positive cancers

     -protein components *(HERS2).

   *HERS2—human epidermal growth factor—the protein promotes growth of the cancer.

  1 in 5 breast cancers are HERS+ and tend to be more aggressive. There are specific targeted drugs to treat HERS+ cancers and improves the cure rate. Breast cancers should be tested for this HERS protein (except for ductal carcinoma in situ-DCIS).

4--Triple negative breast cancer

  Other breast cancers can test negative for all 3 types of receptors, and are called triple negative cancers, which account for 15% of breast cancers and are difficult to treat.

5--Inflammatory carcinoma

  Special types of breast cancers that have inflammatory cells that block lymph node channels and create redness and swelling in the breast. It accounts for 1-5% of breast cancers and very aggressive. Note the redness of the breast tissue below in the photo below.

6--Rare types of breast cancer

  Pagets disease (1-3%), angiocarcinoma-primary or secondary to previous radiation therapy, and Phylloides tumor (mostly benign) make up a rare number of cancers.

The American Cancer Society, Cleveland Clinic

I. Grades of breast cancer

  Just how malignant a cancer cell is, is a factor in determining the outcomes in breast cancer, and the extent of treatment. There are 3 grades-1-mild or well-differentiated, 2-intermediate-moderately differentiated, and 3-high grade or poorly differentiated.

  The higher the grade, the faster the cancer grows and spreads to lymph nodes and other organs.

J. Metastatic Breast Cancer

  Early breast cancers can be aggressive and between 20-30% become metastatic or stage IV sooner or later, and can be difficult to control, even though they are not detected early.

  Understanding the factors that contribute to why they can go undetected help the oncologist in the decision making for more aggressive therapy. All the testing does not necessarily detect these metastatic cells, as it takes millions of cells to finally show up on an MRI, bone scan, or PET scan.

  Bone metastases are the most common sites for breast cancer to spread, more than lungs, liver, and brain. Symptoms can be confused with arthritis, etc. and a high index of suspicion is necessary. Finding genetic markers makes it easier to consider more aggressive therapy even with an early cancer.

  Seven genes have been found to be mutated in metastatic breast cancer (MYLK, PEAK 1, SLC2A4RG, EVC2, XIRP2, PALB2, ESR1). These genes are involved in celluar signaling and conferring treatment resistance.

  Considering who will more likely than not be susceptible to metastases needs to be factored in with chemotherapeutic and other biologic treatments sometimes even before surgery and radiation (adjuvant) and following primary treatment.

  Metastatic breast cancer lower the 5 year survival rate to 29%, according to the AMA EdHub, November 10, 2022.

  Even with this information, breast cancer detected early with testing affords a possible 90+% chance of a 5 year survival rate, and a positive attitude must be part of the concept of curable therapy.

K. Staging of breast cancer

  Staging of breast cancer correlates with survival rates, and must be made in the workup of any cancer. According to the Joint Commission on Cancer, the TNM system is used, and are universally accepted.

T=tumor size, N=spread to nodes, and M=distant metastasis

  Other factors in staging include estrogen and progesterone receptors on the cancer cell, which are proteins (hormones) present on the cells. HERS (Human epidermal growth factor) is a protein that can be excessive in amount on the cancer cells.

  The grade of the cancer cell (as described above as how malignant is cell appears to be on pathological exam) also factors in.

  These additional factors have made the staging more complex, and create more decision making on the aggressiveness of therapy.

  Inumerating the TNM system best to worst is difficult to follow for the reader, and I prefer to have you get the American Cancer Society’s website on breast cancer staging www.cancer.org  The oncologist must explain the entire staging of any woman’s cancer, which allows the doctor to better choose the most correct treatment regimen.

L. The value of a Tumor Board presentation for treatment decisions

  Presenting these cancers to a tumor board is valuable in getting a consensus agreement between a group of expert doctors presented the case all in person.

  This process is often part of the workup and treatment regimen in larger cancer centers. Ask your oncologist about presenting your cancer to a tumor board.

Next month, treatment modalities will be discussed in Part 2 of the breast cancer series.

3. Celebrities with unusual medical conditions— 

     --Facial Palsy, Shingles; Ramsay Hunt Syndrome--Justin Beiber/George Clooney, and Senator Feinstein (D-Calif);

       --Fibromyalgia--Lady Gaga

    A. Justin Beiber/George Clooney, Senator Feinstein (D-Calif)—Facial paralysis from Shingles virus—Ramsay Hunt Syndrome and Viral Encephalitis

Three celebrities developed spontaneous facial paralysis on one side, from two different causes. One from the shingles virus, and the other unknown, likely viral as well.

  Justin developed shingles (from Herpes Zoster virus which as the chicken pox virus is called Varicella virus) which affects the facial nerve and the auditory (hearing) nerve—Ramsay Hunt Syndrome.

   Senator Diane Feinstein developed it too, with a facial shingles rash, facial paralysis (seen above) and encephalitis from the virus. She was in the hospital for 3 months and appears to not have fully recovered yet, and still refuses to resign at 89 years of age (age and term limits are so needed).

The viral infection may appear as meningitis, encephalitis, or meningoencephalitis, and most commonly hits immunocompromised people, who are frail and easily infected.

   It is rare, but occurs in people who are immunosuppressed. Fever, headache, loss of body control, inability to comprehend language, seizures, cough, shortness of breath, and can cough up blood. It lasts only a few days, but will usually take a month or so to recover.

  Intravenous aciclor, an anti-viral reduces mortality and allows a quicker recovery.

  Long term effects can cause memory loss, and behavioral changes, speech, and language problems (aphasia).

  Viral infections of the brain are serious infections, but patients usually recover.  Her ability to serve as a senator is obviously over, and yet refuses to resign. Our government is in so much trouble. Where are the doctors that monitor the health and make medical decisions for our politicians??

Bell’s Palsy

George Clooney developed classic Bell’s Palsy as a young man with eventual complete recovery. Bell’s Palsy usually occurs after some innocent upper respiratory infection, usually viral, including Herpes Zoster.

  Treatment usually involves corticosteroid therapy, sometimes with antiviral therapy (Valtrex, Zovirax) oral. Antivirals alone have no value, so the best part of the treatment comes from reducing the swelling in the nerve as it passes through the boney canals of the skull and mastoid bone. Facial nerve surgical decompression is no longer recommended as it was when I treated these patients when in practice.

  If the paralysis persists, facial reanimation with surgical nerve transplants may be recommended (hypoglossal tongue nerve). Brow lift, narrowing of the eyelid opening (tarsorrhaphy) permanently or temporarily prevents excessive exposure of the conjunctiva. Note the narrowing of the lateral part of the eyelid (arrow). The edge of the lid margin is removed and sutured. It can be reversed.

Before and after tarsorrhaphy

Ramsay Hunt Syndrome

  The rash from the chicken pox (Varicella) virus when it erupts later in life is called Herpes Zoster, and it may cover the ear and one side of the face, even the eyelid in some cases. Pain occurs in the face in the distribution of the facial nerve from the rash but it can affect the skin distribution of the trigeminal nerve, the cranial nerve for sensation, whereas the facial cranial nerve innervates the muscles of the face. Sometimes, the rash does not appear.

  The virus can also affect the hearing (auditory nerve) and hearing loss (a nerve deafness) can be permanent.

  The rash blisters up and then scabs, leaving very red areas of skin after the rash subsides in 2-3 weeks. These blisters are capable of spreading the chicken pox virus to someone never exposed. It does not cause this syndrome.

In George Clooney’s circumstance, he had facial paralysis called Bell’s Palsy as a teenager, with no known cause, but thought to be viral. He obviously recovered fully. The paralysis of the face affects the same nerve with Ramsay Hunt and Bell’s Palsy, but the hearing is unaffected, and the inner ear can create vertigo.

  In Bell’s Palsy, besides herpes zoster, herpes simplex (cold sores), Epstein Barr virus (infectious mono), adenoviruses, rubella, influenza virus, cocksackie virus may cause the palsy. Patients with diabetes, pregnancy, hypertension, and obesity tend to be at higher risk.  

  This Ramsay Hunt Syndrome, and as an ENT surgeon, I took care of these patients. Hearing loss can be permanent although may return partially or close to complete. The virus resides in the geniculate ganglion of the facial nerve inside the brain.

  When the chicken pox virus is activated, the virus travels down the nerve to the skin that is innervated by the specific nerve, the 7^th cranial nerve, in this case. This is true whether the virus hits the face, the trunk, back, or elsewhere as all are caused by involved with Herpes Zoster virus.

  Fortunately Ramsay Hunt Syndrome is less common than affecting nerves between the ribs and aroud the chest skin.

  The disease lasts a few weeks but the facial weakness may not disappear and could be reactivated years later, since shingles can occur more than once. If the facial nerve does not disappear, there will be certain procedures to protect the eye (tarsorrhaphy to close the outer side of the eyelid), facial nerve transplants using the hypoglossal nerve.

The facial nerve traverses the mastoid bone (part of the skull holding the ear) very near the inner ear, and that is why the virus in Ramsay Hunt affects hearing as well, to be diagnosed as Ramsay Hunt. Dizziness can also occur since the balance nerves are in the inner ear as well (cochlea). Loss of taste can occur from inflammation of taste nerves.

  Intermittent and recurrent facial paresis or paralysis has been found to occur in 4-7% in patients diagnosed with multiple sclerosis, an autoimmune disease. It is well known that patients with MS can present with a constellation of weakness throughout the body. JAMA Otolaryngology, April 6, 2023

  When facial weakness occurs, regardless of cause, the eyelid is paralyzed as well, and the lower lid sags, making it very difficult to close the eye, causing irritation and inflammation of the conjunctiva and cornea. Saliva can leak out of the side of the mouth. The speech is affected since the facial animation is affected.

  The facial nerve can paralyze from a stroke as well.

  The virus will not cause shingles, but can cause chicken pox in children, immunosuppressed, and pregnant women more frequently. People over 60 are more likely to develop shingles anywhere in the body, and those immunosuppressed. All will have had chicken pox in their lives to have shingles.

  There is a distinction between central and peripheral facial paralysis. Viruses are the most common cause of peripheral palsy, but stroke is the most common cause of central paralysis, diagnosed with an MRI.

  Usually the muscles of the forehead may be spared in central palsy, and is caused by a stroke on the opposite side of the brain. Dizziness, unsteadiness, and difficulty in swallowing may occur as well.

Diagnostic procedures for facial paralysis

  EMG—electromyogram will determine the amount of the damage to the 7^th cranial nerve, but is not necessary to diagnose the condition, rather it may help as the movement starts to return.

  MRI—may be suggested if a tumor, MS or stroke is suspected.

  Blood tests for Lyme disease may be recommended in Bell’s Palsy patients.

Treatment

   Therapy for Ramsay Hunt Syndrome and Bell’s Palsy may be the same if a viral cause is suspected in Bell’s, but certainly for Ramsay Hunt patients. Zovirax, Famvir, or Valtrex is used to treat the virus, and if severe, may require admission for IV therapy.

  Corticosteroids are used to enhance the effects of the antivirals, and redce the swelling in the facial nerve, especially as it traverses the soldi bone of the mastoid.

  Valium is used to relax the patient and help the vertigo.

  Pain medication may need to be prescribed for the facial pain. NSAIDs help as well. Cool compressed for the rash, and protection of the eye. A humidifier by the patient helps keep moisture in the eye, as well as eye drops to lubricate the dryness of the eye.    

  As mentioned above, with permanent paralysis, nerve transplants can be considered plus procedures to protect the eye.

  Justin and George were lucky to have recovered well.

Mayo Clinic

  Some patients who develop facial paralysis may develop synkinesis, unwanted contractions of the facial muscles during attempted movement. Forceful eye closure when smiling is the most common. Facial nerve retraining with rehab may be helpful, but surgical procedures may be necessary if significant. Botox may be helpful in selected spots of the face or eyelid.

Shingles of the face

4-12 people per 1000 per year develop shingles, a chicken pox, older than age 65. If a person develops this virus any time as a child or adult carry that virus the rest of their life. The virus lives in the ganglia and nerve bodies off the spinal cord.

  When shingles (Varicella) is activated for a number of reasons, the virus travels down the nerves to the area of the skin where that nerve supplies, and once the virus gets close to the skin, the area becomes irritated, and begins to burn. The area may ache, and cause fever, fatigue, and forms red spots along the skin, which then blisters and scabs in about 7-10 days.

  Complications can occur by invading the eye, the brain (aseptic meningitis), cranial neuropathies (pain, paralysis) including Bell’s Palsy and hearing loss (Ramsay Hunt Syndrome).

  Recent studies found that those who were vaccinated with Shingrix can reduce the risk of dementia can occur, but the infection does not increase the risk.

  People over 65 should strongly consider getting the new vaccine (Shingrix) and all those with immunocomprised medical conditions should seriously consider this vaccine,   for those 19 and older. While others can get one dose, two doses are recommended for those compromised.

  The 20% that can develop post shingles neuralgia with long standing pain, even permanent. Acupuncture has been reported to reduce the posterior neuralgia rate, although it does not reduce the intensity of pain.

  Pulsed radiofrequency can improve the pain intensity. Short term spinal stimulation also can be of help, and both help post herpetic pain.

  Coadministration of pneumococcal and Varicella vaccines are seem to help prevent shingles, and could receive both vaccines simultaneously.

Medscape, Dec. 22, 2022

  B. Lady Gaga—Fibromyalgia (Chronic Central Hypersensivity Syndrome)

  Although not as rare as some disorders, and I have discussed this before, but it is a good time to remember that fibromyalgia is only a part of a spectrum of autoimmune diseases, now called central sensitization (hypersensitivity) syndrome, which includes and can superimpose over most autoimmune diseases from rheumatoid arthritis, lupus, and many other rheumatoid diseases that affect the nerves of the body that create exaggerated responses from the brain to the body’s nerves with fibromyagia, chronic fatigue syndrome, and many other disorders.

Causes

  Often fibromyalgia may occur after an infection, surgery, physical or mental trauma.

  Fibromyagia can cause muscle pain anywhere in the body, is bilateral, and can be quite severe in some cases, which can come and go. It is also associated with fatigue, sleep, memory, and mood issues. Brain fog is becoming a common symptom in many diseases including fibromyalgia, and many of these symptoms appear in COVID cases, both acute and long COVID syndrome.

  Tension headaches, TMJ (temporomandibular joint syndrome, IBS (irritable bowel syndrome), anxiety , and depression can occur. Women are affected more commonly as in most autoimmune diseases.

  Technically for a patient to be diagnosed with fibromyalgia, there needs to be 4 out of 5 body regions involved.

Diagnostic tests

  Blood tests include CBC, sedimentation rate, cyclic citrullinated peptide (finds abnormal antibodies in fibromyalgia), which can be the antibodies that attack tissues abnormally. Rheumatoid factor, thyroid functions, ANA (antinuclear antibodies), celiac serology (another test for antibodies) including those in celiac disease, another immune disease due to gluten sensitivity.

  Vitamin D levels may be low, which can occur in many autoimmune diseases. Taking supplements is often recommended even with normal blood levels, because some experts hypothesize that the Vitamin D is not well utilized in these autoimmune diseases.

Treatment

  Pain relievers include NSAIDs (non-steroidal anti-inflammatory drugs), but opioids should be avoided because any chronic pain syndrome can lead to abuse and addiction.

  Antidepressants are often helpful to cope with the symptoms.

  Anti-seizure medications are often prescribed (pregabalin-Lyrica and gabapentin-Neurontin). These drugs are being over used in many cases by doctors trying to keep patients away from opioids.

  Alternative therapies can come from physical therapy, massage therapy, yoga, acupuncture, chiropractic, occupational therapy, and counseling. Good nutrition, weight control, and regular exercise are always helpful, especially when fatigue urges a patient to stay on the couch. Motivation and willpower are always critical. Living with any chronic illness requires diligence in deling with it daily.

Mayo Clinic

4. New drug may be good alternative for statins—Bempedoic Acid 

   Bempedoic acid (Nexletol) has been reported to lower LDL cholesterol just as statin. Ezetimibe (Xetia), a fat blocker, does as well. The combination drugs are even better.

  Bempedoic acid does not cause muscle-related side effects. It appears to be a good alternative for those sensitive to statins or those who cannot take higher doses of statins. Physicians are encouraged to use the highest dose of statins tolerable.

  This newer drug does have significant cardiovascular event reduction capability, but the article stated that it is not ready to be recommended as an alternative to statins, rather only for those intolerant of statins, and only in those with known cardiovascular disease. All of the side effecs and drug interactions must be analyzed.

  Do not take this drug with these 2 statins—simivastatin, pravastatin, as they may increase muscle pain. Also it is critical the prescribing doctor is aware of all conditions of the patient including gout (can increase uric acid), muscle problems, tendon problems, heart, liver, kidney, or strokes.

  There has been no study comparing bempdoic acid to statins.

  NEJM, March 4, 2023; Mayo Clinic 

5. Infectious Hepatitis A, B, C; Complications of cirrhosis of the liver

  There are three types of hepatitis, and the differences need to be understood. There is overlap, but will be differentiated. All can have serious consequences with the liver and other organs, and will be discussed.

Hepatitis A

  Hepatitis A is very infectious and caused by a virus that causes inflammation of the liver (hepatitis) coming from contaminated food, water, or someone infected with it (close contact or sex) from Mexico, Central and South America. That means all those illegals coming across the southern border potentially are infected. Any areas of poor sanitation are of concern. Eating at a restaurant in any of the above countries, or drinking their water can be a significant risk.

  Most people infected with a milder case will recover completely without liver damage.

  Hand washing, good hygiene, getting a Hepatitis A vaccine, and avoiding anyone sick.

  Symptoms can mimic most viral illnesses with tiredness, weakness, sudden nausea, diarrhea, abdominal complaints, clay or gray colored stools, loss of appetite, low grade fever, dark urine, joint pain, yellow skin and eyes from jaundice, and intense itching from bilirubin, the protein that rises in the liver from damage.

  Most recover in a few weeks, however, if more severe, will last longer, and all these patients need to be tested and evaluated.

  The virus will be in feces contaminating food crops, eating raw shellfish, or eating food prepared with fecal contamination from cooks.  Casual contact, being sneezed or coughed on does not spread the virus. The virus can live on surfaces for a few months. Men having sex with men are at increased risk, those who are HIV positive, homeless, and those who use recreational drugs.

  Unless contraindicated by your physician, everyone should be vaccinated, and certainly, if going to the countries where it often found. Most doctors have a list.

Treatment

  If someone is diagnosed, liver function studies will be abnormal, and must be followed. Rest, a balanced diet, avoidance of alcohol, are recommended, but if nausea is a problem, small meals would be better. Extra hydration is important. Avoid sex, practice extra hygiene, do not prepare food, and avoid most people, certainly those elderly, immunosuppressed, and children.

Hepatitis B (HBV)—vaccine available

  Hep B is more of a serious form of liver infection from the hepatitis B virus, is somewhat acute, and lasts less than 6 months, although infants and children tend to have more protracted illness.

  Although most patients recover, there is a chronic form, which can lead to chronic hepatitis, cirrhosis, and liver failure, including liver cancer (now one of the more common causes of liver cancer).

  The symptoms may be absent, especially in younger people. They usually appear 1-4 months after being infected, and will be infectious before symptoms. The symptoms are the same as in Hepatitis A, but when the liver becomes more inflamed, the symptoms could increase.

  Contact a doctor as soon as one is exposed, as preventative treatment may help prevent infection if received within the first 24 hours.

  Causes include having sex with someone infected (who will probably be asymptomatic), sharing needles for drugs, an accidental needlt stick especially for health care professionals, and pregnant women infected can pass the virus to their child during childbirth. Newborns can be vaccinated to prevent infection. All pregnant women should be tested. Those who are immnosuppressed from illness or medications that treat many diseases including rheumatoid diseases, cancer, and anyone receiving corticosteroids regularly. Prisoners are at risk and need vaccination.

Acute Hep B lasts less than 6 months, and with a good immune system, will recover completely, but can go into a chronic form.

Chronic Hep B can occur in anyone with an impaired immune system for any reason, certainly someone chronically ill, have HIV, cancer, etc. The chronic form can last a lifetime, leading to cirrhosis, liver failure, or liver cancer. It can reactivate back to an acute form. The illness may go undetected for decades. The kidneys and blood vessels may become inflamed as well.

Vaccination is recommended for all 19-59, newborns, children and adolescents not vaccinated at birth (I hope the illegal border crossers are getting the vaccine). All healthcare workers or those working or living in centers for the disabled, anyone with HIV, men having sex with men, people with multiple sex partners, drug addicts, people with chronic liver or kidney disease. Anyone living with someone with chronic Hep B, and traveler going to 3^rd world countries known to have Hep B. Those who get tattoos or piercings should consider it strongly. Those who were born or have an adopted child in a country known to have Hep B including Asia, Africa, Pacific islands, and eastern Europe.

  The vaccine can be given in 2 injections a month apart, or may be given in 3 injections  over 6 months.

  Avoiding injectable illicit drugs, using condoms, knowing the status a sex partner, are just some common sense avoidance techniques. If getting a tattoo, ask about sterilization techniques and is a very reputable store.

  Diagnostics include liver function and kidney function studies, liver ultrasound, and a liver biopsy using a needle if disease is present especially the chronic form.

  Treatment, if exposed within 24 hours, should include immunoglobulin injections including the vaccine.

Acute infection, if mild, may only need common sense measures may all that is needed (rest, hygiene, etc.). Immunoglobulins (usually gamma globulin) maybe given.

Chronic infection, those with Hep C as well, HIV, immunosuppressed by illness or medication needs treatment.

   A) Antivirals—Baraclude, Viread, Epivir, Hepsera, and telbivudine can slow the progression of liver damage.

  B) Interferon-alpha A (Intron-A) injections are used for younger people, women who want to get pregnant for a period of time. While taking interferon, women must use contraception to prevent possible damage to the fetus.

  A liver transplant may be necessary if the liver fails thorugh the process of cirrhosis.

Hepatitis C 

  Contaminated blood is the source of Hep C. Treatment was complicated in the past, but now intead of injections, there is an oral form of medication that can be taken daily for 2-6 months and potentially cure this disease. Sadly, half of the people infected donlt know it, because they are asymptomatic, which can take decades to appear. Fro that reason, all people 18-79 should be screened for Hep C, even if asymptomatic or not having known liver damage.

  All patients have an acute phase and are often asymptomatic. if symptomatic, the symptos mimic the other two types of hepatitis and can be successfully treated with antivirals and immunogloulins. As many as 25% with acute Hep C will spontaneously clear the virus.

   Once symptomatic in the chronic phase, the liver damage as progressed with easy bruising and bleeding, fatigue, poor apetite, jaundice, itchy skin, ascites (fluid buildup in the abdomen), leg swelling, spider like blood vessles on the skin (spider angiomas), weight loss, and with severe liver failure (hepatic encephalopathy—confusion, drowsiness, slurring of speech).

Cause

  There are 7 genotypes globally, and type 1 is the most common type in the U.S.

  Anyone exposed to blood can be infected including healthcare workers, those injecting illicit drugs, have HIV, had a piercing or tattoo, blood transfusion or an organ transplant before 1992, received a clotting factor concentrate (those with hemophilia, ec.), those receiving hemodialysis, were born to a woman infected, were in prison, and were born between 1945-1965 (5X more likely to be infected).

Complications are the same for anyone who develops severe hepatitis—cirrhosis (scarring of the liver), liver failure, or liver cancer.

Diagnosics include tests for the viral load of Hep C, liver and kidney function studies, identifying the genotype of Hep C, liver biopsy, or an MRI, a special toy of ultrasound (transient elastography).

Treatment depends on the genotype of the virus using specific antivirals. The goal of the treatment is to have no virus in the blood within 12 weeks after treatment. The length of treatment depends on the damage to the liver.

Liver transplantation is the last resort but can give the patient a normally functioning liver and save their life.

THERE IS NO VACCINE TO DATE FOR HEPATITIS C.

Mayo Clinic information

Screening for Hepatitis

  Screening for Hepatitis B for all adult should be performed at least once in a lifetime, according to the CDC. Between 600,000 and 2.4 million individuals are carrying a chronic Hepatitis B infection without symptoms and 2/3 are unaware of it. Pregnant women should be tested in the first trimester. The test includes a triple panel for initial screening.

  There are 4 groups who are considered higher risk—incarcerated, people with a current or past hepatitis C, and people with current or past sexually transmitted infections, and those with multiple partners. Those who are immunosuppressed are higher risk, regardless of reason. 

  Hep B vaccine is highly recommended. There is no curative therapy for HBV, but diagnosis and treatment of chronic infections reduces the risk of cirrhosis, liver cancer, and death.

  The virus spreads through contact with blood, semen, and other bodily fluids.

CDC Morbidity and Mortality Weekly Report, March 10, 2023

Complication of Hepatitis—cirrhosis of the liver

Inflammation of the liver can occur from any type of hepatitis, mostly Hep C (41%), alcohol (45%), non-alcoholic cirrhosis (26%),  but also from poisons, chemicals and some medications.

  2.2 million adults suffer from cirrhosis in the U.S.

  Fatty liver occurs in diabetics, and those with very high triglyceride fats in the blood. With inflammation and fat infiltrating the cells, scarring occurs causing enlargement of the liver, but as the scarring (cirrhosis) continues, which can take years, back up of pressure in the veins of the liver (portal hypertension) enlarge the spleen, and dilate the blood vessels in the lower esophagus (varices), which can bleed severely.

   Endoscopy should be done if patients throw up blood, are anemic, or have black tarry stools. Back pressure from the liver creates oozing of fluid from the liver, which builds up in the abdominal cavity (ascites). The kidneys can fail (hepatorenal syndrome) as well. 1-4% develop liver cancer each year. Hepatic encephalopathy can occur in late stage disease with disorientation, cognitive difficulty, imbalance, falls, car accidents.

  Patients with cirrhosis experience itching (41%), muscle cramps (64%), poor quality sleep (63%), and sexual dysfunction (53%). Patients develop yellow jaundice.

Workup

  Elastography to measure the stiffness of the liver has become an important noninvasive test, which might prevent a liver biopsy.

  Ultrasound of the liver is an important test to monitor the liver for cancer in addition to alpha-fetoprotein blood test may be necessary. All of these tests provide a monitoring system besides liver and kidney function studies. Low blood serum albumin, high bilirubin, INR* (international normalized ratios) and creatinine levels, low sodium blood levels, plus liver enzyme tests implie lower survival.

*INR=prothrombin time, a blood clotting study

  Portal hypertension can be measured using a catheter inserted into the jugular vein to measure the pressure.

  Treatment with hydroxyzine improves sleep, terlipressin reduces hepatorenal syndrome, cholestyramine for itching,  pickle brine and taurine improves muscle cramps, and beta blockers in combination with aldosterone can improve ascites. Cessation of alcohol is a must, regardless of the cause of cirrhosis. Antibioitics for bacterial peritonitis is usually treated with ceftriaxione, a third generation od cephalosporins can reduce mortality from 41 to 22%.

  Complications bedside esophageal varices, splendid and liver enlargement, and ascites include peritonitis from the fluid in the abdomen getting infected, which can be diagnosed with a needle to remove fluid (peritoneal paracentesis). Low blood platelets (thrombocytopenia) is not uncommon in cirrhosis, which can increases bruising and esay bleeding.

  Any small masses in the liver on ultrasound with an increasing serum alpha fetoprotein (secreted by the cancer cells) should be biopsied for liver cancer.

  4% of those with cirrhosis develop liver cancer, but 80-90% of those with liver cancer have cirrhosis.

  Hepatic encephalopathy has a 1+year survival, therefore, treatment must strive to prevent this brain toxicity. When the toxins that not metabolized, they accumulate in the blood and damage the brain. It is a form of an encephalopathy, and is often fatal, as in cases of end stage cirrhosis.

JAMA Network, May 9, 2023

6. A new drug that might enhance libido, sexual arousal—Kisspeptin; new topical gel to improve erections

  The neurophysiological pathways in the brain predispose to low sexual desire, and the most common form is hypoactive sexual desire disorder, which affects 8% of men with low testosterone levels. The reproductive neuropeptide, kisspeptin, appears to help this issue.

  It enhances the limbic responses to sexual and bonding stimuli, improves mood, and reduces sexual aversion.

  Studies were performed using IV infusions and in a study it increased LH and serum testosterone. Stimulation of hypothalamic neuropeptide is obligatory for normal pubertal maturation.

  Just who would respond better remains to be seen, but further research will be sure to come.

  There is also a gel to improve erections supposedly that will soon be sold over the counter, and will sure to be a success, even as a placebo.

  Interestingly, the kisspeptins were originally developed to suppress cancer metastases. I have yet to read any solid data that would not require more controlled studies for the FDA to look at it.

NIH, 2017

 Erectile gel OTC (Eroxon) has been authorized by the FDA to be marketed (different than approval). It apparently takes about 10 minutes for the gel to help create an erection and was maintained long enough to achieve a satisfactory. Can’t find any real data, but if it cheap, could be worth a shot, but sounds like just maybe the cooling and then the warmth may be the real value in foreplay. Washington Post

This concludes the July, 2023 report.

The August, 2023 report will include:

1. Late Breaking Medical News

2. Breast Cancer Series-part 2--treatment

3. Mood disorders

4. Life’s essential 8-to extend life span

5. Obstructive sleep apnea CPAP machines recalled a second time

6. Celebrities with unusual diseases-part 4—Sam Neill, Christina Appelgate, Billie Elish

Enjoy the summer, the independence of our country, friends, and family, and stay healthy and well, my friends, Dr. Sam