The Medical News Report

May, 2023

#136

Samuel J. LaMonte, M.D., FACS

www.themedicalnewsreport.com

Subjects for May, 2023

1. Quick notes about breaking news—Transgender mass shootings and women sports; Narcan over the counter; Xylazine and Fentanyl worse; COVID updates; Vaccine effects on cosmetic dermal fillers; Sleep apnea CPAP Philips) machines recalled a second time; a word on socialism

2. Bipolar Disorders 1 and 2

3. Celebrities with unusual medical conditions—Part 1--Terry Bradshaw-cancers; Celine Dion-stiff body syndrome; Alan Jackson-Charcot-Toothe syndrome;  Bruce Willis-frontotemporal dementia

4. Child Abuse and its consequences as adults—Part 4 of the series on mental disorders in youth

5. FDA needs to improve!

6. Eldercare crisis

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. If you want this monthly report sent to your private email address, just email me samlamonte@gmail.com

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.

Thank you, Dr. Sam

1. Quick notes about breaking news

   a. Transgender mass murders; Transgender sports competition(Title IX)

The transfemale, in the Nashville school shooting, obviously had animosity toward the Christian community (and religion) and took out anger on “her” previous Christian school, their administraton, staff, and students (Judeo-Christian discrimination).

  Those wanting to commit suicide often project their feelings on others, when they kill others, expecting to be shot by police.

  According to Newsweek, there have been 4 mass shootings perpetrated by transgender people in the last 5 years, all biological males, and this one too. Some are pointing the finger at the hormones being taken to transition as the cause, but clearly these people have a load of emotions that create aberrant behavior.

  “The trans movement is pushing more and more extremism each day”, according to Oli London, a media personality, who de-transitioned and has been very critical of that community. The indoctrination and propaganda promoted by them is rising, filling them with hate and rage on top of their very high psychological disorders. They are being used by the radical activists to create more havoc and chaos in our country, using their gender changes as a weapon. On the other side of the coin, an LBGTQ club in Orlando had a mass shooting from anti-gay people. This has got to stop.

  Bipolar disorders are often diagnosed in this community, which will be reported below.  

Transgender sports competition (Title IX)

Riley Gaines, swimming athlete, standing up for women’s sports and against transfemales competing against them , as she was beaten by Leah Thomas (trans) in the NCAA women’s championship as Riley came in second. When competing against men, Thomas was 124^th.

  Title IX prohibits sex discrimination at educational institutes that receive federal funding (as much as 10-20% of a school’s revenue). Now this federal law is going against women, when they were protecting them prior to the trans issue.

   The administration proposed a rule change that would prohibit schools from “categorically” banning transgender students from athletic teams that are consistent with their gender identities (not biological sex).

  It would allow schools to block some transgender athletes from competing on sports teams that match their gender identities. But the proposal would also prevent schools from enacting across-the-board bans. Can you see the divisiveness in this ruling? It will create constant controversy on how this ruling is interpreted, and ultimately destroy women’s sports. That is exactly what the administration wants, as they are governed by controversy, separation, crises, misusing our beloved constitution, and promoting socialism and censorship.

  It would give universities and K-12 schools the discretion to limit the participitation by them if it was deemed harmful undermining competitive fairness or create unnecessary sports related injuires, a key part of the debate about transgender athletes in women’s. This will create total chaos in the decision making.

  Equal opportunity is at stake (while promoting unfair equity) pitting transwomen against biological women, which has already caused serious issues for women competing in sports.  

  According to the New York Times, elementary school students would be able to participate in school sports according to their gender identity, under this proposal. But at more competitive levels, including high school and college sports, bans could be placed, but will create lawsuits, and division in women’s sports.

  The specific sports would also be contentious and further creating unfairness for biological women. Where are activist groups to support women, such as Me-Too, all women athletes, and national women’s activist groups?? Be sure the LBGTQ community will be highly active in fighting for this issue, and ultimately continue to separate our country with yet another “rights issue” made totally political.

  These leftist groups continue to foster splitting of our country which is one of the major factors in promoting socialism/Marxism. These trans activist are out of control and physically attacked Riley Gaines, a biological female swimmer at the University of Kentucky, speaking at San Francisco State University on free speech. Our country has become a bunch of activist lunatics.

Let the girls compete against girls!! 20 states ban gender affirming therapy before age 18 (add Kansas to the above states). This administration’s meddling is only to continue the political heat and pave the way for a series of discrimination complaints from parents and families, challenging school districts, etc. influencing elections.

  Using women, the university level is now the focus of young people raging with anger and taking it out on conservative ideology. Earlier this month, another destructive protest occurred at a freedom of speech rally at the University SUNY (Albany).

  Polling suggests a majority of Americans are opposed to participation by trans gender women and girl’s in women’s divisions. These activists don’t care. NYT, April 6, 2023

  This issue is separate from gender affirming therapy, which I covered in depth the past 2 months.

   b. Narcan now available over the counter; Xylazine now making fentanyl more dangerous

Opioid overdoses are epidemic, and if nasal or injectable Narcan is used in time, it reverses the respiratory depression created by these drugs, especially fentanyl, responsible for 80% of the deaths (112,000 deaths total). This product will include 2 nasal spray bottles, as it may take more than one spray to reverse the narcotic. One is usually enough, but some cases will require a second dose. Price is expected to be $50. FDA

  Xylazine making fentanyl more dangerous

  The veterinarian drug xylazine (a tranquilizer) extends the length of fentanyl’s effect, a very dangerous drug when laced in other drugs without proper dosing. It has become a national crisis that even the Biden administration has finally decided to acknowledge, and has authorized federal funds to counteract the drugs. Only $11 million dollars was allocated to stop its spread and develop an antidote and research how this got into the nation’s street drug supply (like that Is not known). AMA Morning News, April 13, 2023  

  c. COVID updates

 -- Long COVID

   It is a clinical diagnosis (as high as 15% of those mostly who were hospitalized with COVID). There is a long list of symptoms and length of time in defining this syndrome.

   Some of the latest demographics points to higher risk people, who are more likely to get it. Here are some of them: unvaccinated, women, over 40, smoker, those overweight, and those who were hospitalized. Those with anxiety or depression, diabetic, asthma, or were immunocompromised.

  Why are these patients getting long COVID? Still not known after 3 years!! The risk factors are not surprising. Vaccination for healthy people continues to be questionable, but with so many people in some risk category, it seems quite reasonable to get the basic vaccine doses and a booster within 6 months. Also, if at higher risk, an annual booster is probably smart as well, but I question for healthy younger people. And yet, post vaccination side effects continue to worry people as well with more information being presented. The latest is 5% develop tinnitus (ringing in the ears), and it is vert annoying. Loss of smell is another difficult side effect, because it affects taste.

  A recent study found that people just infected with COVID, who took Metformin (the diabetic oral drug) were less likely to develop long COVID vs placebo (6.9 vs 10.6%). We will see if other studies back this up. We certainly know that having been vaccinated, with an infection, drops the risk in half to develop long COVID.

  When the body’s immune system is manipulated by infection or a vaccine, it is clear to me, this syndrome is a form of autoimmune response, similar to all the autoimmune diseases such as rheumatoid diseases, lupus, fibromyalgia, rheumatoid arthritis, psoriasis, etc.

Medpage Today, March 21, 2023

  d.Over the counter INFLUENZA/COVID nasal test now available for 14 and older; No need for children’s COVID vaccine; comparison of flu and COVID

   Most experts I follow continue to question any healthy children being vaccinated. With probably 90% of the population vaccinated, infected, or both, have immunity. Newer information about T cell memory, which is quite long lasting after infection or vaccination, may put some doubt in the need for annual boosters. While data continues to be collected, there is no agreement about these annual shots (except the government and Big Pharma, who is making all the money, also supported by Big Medicine).

  Even the WHO no longer recommends annual boosters for healthy individuals, but those at risk may need more than one, because the boosters don’t even last 6 months, according to data from Qatar. The FDA now approved a second annual booster for the vulnerable supported by the CDC.

   Pregnancy warrants a booster according to the CDC and the WHO. Children, unless at risk probably don’t need vaccines, according to many experts, and it takes $5 million worth of vaccine to save one life for those 15 years and younger.

  Although, I maligned the WHO for quite awhile because of their being compromised by China, they make more sense than the CDC at times. Unfortunately neither organization always makes decisions based on sound medical data. And now there is discussion for the U.S. to allow the WHO to decide how to manage future pandemics, even in the U.S. (OMG!!)

Medpage Today, march 30, 2023

  If either the flu or COVID test is positive, please notify a personal physician, and discuss getting Paxlovid if high risk, and Tamiflu for flu.

JAMA Network, March 8,2023

  You can still apply for COVID tests from the government.

   e. Flu vs COVID

  Flu and COVID have both had their influence this year, but the death rates and hospitalizations have dropped considerably since the first year of the pandemic.

  In a VA population study, the investigators found that COVID was still 2-3X more likely to require hospitalization, but the death rates in 2020 was 17% for COVID and has dropped to 6%, while flu death rates dropped from 3.8% to 3.7%.

  Immunity, vaccines, infections and re-infections, all play a role in the decrease. Continued vigilance is necessary for hand washing, avoiding crowds in vulnerable people, even though there continues to be a drop in the severity of the variants as mutations continue to occur.

  Remember, a VA population is older, male, and more vulnerable. The general population’s hospitalization and death rates are much lower.

  The CDC no longer tracks case statistics as they once did, because the numbers were often fraudulent and wrong, and no one believed them anyway. It just caused more doubt in the public’s mind about the believability of the CDC because of the loss of credibility thanks to the likes of the Fauci’s and the lying media. And now a recent CEO of the CDC (Dr. Redfield) has cast extreme doubt on the origin of COVID being from a fish market, stating that recent data strongly believe the virus was leaked from the Wuhan Lab. JAMA Network, April 6,2023

  f. Surgery after recovering from COVID

  Patients who have recovered from COVID for 30-60 days, have twice as likely chance of having a postoperative complication (4.7% vs 7.6%) within 30 days after surgery, according to the Academy of Anesthesiology. Delaying surgery when possible is a strong consideration that must be discussed with a patient’s doctors.

  g. Cosmetic dermal fillers--COVID vaccines and their effect on them

  Having great interest in cosmetic dermal fillers having performed them often in my practice of facial plastic surgery, I have heard anecdotally that dermal fillers don’t last as long if a person has received the COVID vaccine. However, I can’t find any good data to support this.

  Having reviewed what data is available from Moderna and what is on the internet, it is clear that if a person gets a COVID vaccine shortly before or after injections of dermal fillers (Radiesse, Juvederm, Belotero, etc.), there could be a more significant reaction when receiving the filler. It is also possible that the vaccine site may react more significantly. This however is very rare, but has been seen in dermatologists and plastic surgeon’s practice. Discuss this before considering cosmetic fillers.

  Hyaluronic acid is the chemical in many of the fillers and initiates an expected reaction in the tissue lasting for weeks to months, filling in facial wrinkles, creases, lines, etc. Although, there can be some reaction with any of these fillers, and if more dramatic, may require a short course of cortisone (Medrol Dosepak, etc.).

  It is recommended not to get a vaccine for at least 2 weeks after a dermal filler, since both the filler and the vaccine are going to initiate an immunological response normally, and the combination may accentuate reactions.

  If a person develops a COVID infection, they should wait 3-6 months to get a vaccination to get the full effects of the vaccine. Those with underlying diseases need to protect themselves from COVID and the Flu, and certainly more important than wrinkles. Complete recovery of a 3 months before getting these fillers might be prudent.  

  A delayed reaction after fillers as much as 4-6 months later after a vaccine can rarely occur. Seeking immediate medical attention is obvious.

  Those who have more reaction with each dermal filler might consider asking the doctor to consider taking an antihistamine before and after an injection.

  Obviously, before considering cosmetic dermal fillers, a consultation is necessary to consider all the risks and benefits, and the type of fillers available, before accepting them. Be sure the PA or doctor is very experienced and the clinic consulted has a good reputation for these minor cosmetic procedures. Don’t trust anyone not trained professionally and has the capability of treating an acute allergic reaction.

www.ncbi.nim.nih.gov (The National Library of Medicine)  

  h. CDC has new recommendations for the current bivalent booster

  The bivalent booster is still being recommended, but now the CDC has approved a second booster for more vulnerable people including those over 65. I hope they can back up that recommendation with sound data.

  As we know, the bivalent booster is not any better than the original booster, which is no longer available. In fact, the CDC is now calling the booster, not a preventative, but just a booster to reduce the severity of an infection, should a person get infected.

  What is not being considered with their decision making, is that there continues to be T cell immunity (separate from the antibody response) that has a memory for years, and even though the antibodies from the vaccine or an infection wanes, these T cells keep the ability to remember, and if challenged by another infection, will fight it. This is why some of the experts, even on the FDA advisory committee, question whether we even need an annual booster. We need more data. Just how much money does Pfizer and Moderna need? Ask the administration, who is in the back pocket of Big Pharma—Big Government and Big Medicine.

  For now, only 16.4% have received the bivalent booster since last September, a reflection of the country’s lack of confidence in the CDC. The number of people testing positive for COVID in the hospital (all are tested), has dipped to 5,738 as of Wednesday, April 3. We are not in a pandemic, but it is still around.  

  i. Sleep apnea CPAP machines (Philips) recalled a second time

  2 years ago, Philips Respironics Dream Station 1, CPAP machines were recalled by the FDA, because the ring in the machine to lower the sound was found to contain contaminates that could cause cancer (5 million of them). They were sent back to the company to refurbish and supposedly made safe back to patients, but they aren’t working or didn’t deliver the proper synconization for the needed pressure. Machines were assigned to the wrong serial number, which can assign the incorrect prescription settings. 1,088 machines are involved. Patients were sent letters regarding the recall, phone calls. People should call 1-877-387-3311. Medscape, April 10, 2023

  j. A word on Socialism/Marxism

  I have been reporting on the transformation of our country to socialism/Marxism. Many feel we are almost there. When one looks at the world, the wars, the terrorism, and the total dysfunction of the U.S., you understand what I have been discussing for the past 2 years.

  Socialized medicine is part and parcel of socialism/Marxism, so is poverty, chaos, open borders, drug crises, separation of races, and the loss of a middle class. Now, the administration is going to penalize those with a credit rating of 680 or better charing them more for a mortgage, and discounting those with poorer credit. How is that fair…..wait ‘til socialism takes over…on the way to communism.

  Medicine is already showing serious deterioration, as doctors and nurse are bailing out of healthcare by the thousands.

  Nurse practitioners and PAs are taking over primary care in smaller cities, the emergency rooms are overrun and less trained staff are having to fill in the gap. We are facing loss of preventative care, chronic disease management, and a country only focused on acute and urgent disease. Just look at any socialized medicine country, and that their way of managing healthcare.

  A definition on the internet from America Greatness defines socialism perhaps better than I could possibly do:

I suppose it is quite obvious that they use the word equal, when in fact, the word is equity today, which means everyone gets the same regardless of education, work, effort, race, income, etc. Where is the motivation for excelling?

  We have one last chance to change America…..the 2024 election. Get involved, support candidates that want to keep our country free, with freedom of speech, getting rid of censorship, strengthen our military, but be prepared for very difficult times just ahead. The U.S. weakness displayed to the world is going to hurt us tremendously.

  God is part of that equation, as communism does not allow religion. Secularism is rampant!

  The Gen Z generation (up to 23 years old) has already been indoctrinated with CRT, wokism, and most are totally happy with socialism, being entitled by many parents who are creating a very weak future for our country.

  The left is more organized and much better team players than moderates, independents, and conservatives. Activism is their middle name. Want a better administration than we have now? We must fight for it. We must have the best candidate to the radical left, the TV and internet media, and the monster corporations. And now we must be concerned about AI interfering!! Pray!!

  For those who are stuck on strict principles for preventing abortion are giving the radical lefts the very issue that will keep Repubs out of the White House in 2024, and all will be lost for good.  

2. Bipolar disorder

Kanye (“Ye”) West, famous rapper and controversial celebrity, previously married to Kim Kardashian, was interviewed on Tucker Carlson (Fox News Channel) for 2 nights, and was a very interesting conversation with someone who is a professed bipolar disorder patient.

  The media has tried to destroy his reputation as he is a vocal supporter of former President Trump. But now he has made some derogatory statements about the Jewish faith and created quite a stir. His bipolar disease is no excuse.

  If you have ever been exposed to someone for a period of time who has this disorder, you will likely only see them when they are in their manic phase, as the depression phase they suffer from usually has them home in bed or by themselves in a deep “funk”.

  When manic, they are creative, talkative, often hyper-excitable, the center of attention in groups with unusual behavior in many ways, seductive, usually enjoyable to be around, and full of energy.

  The amount of manic and depressive phases varies widely in patients. There are many celebrities with bipolar disorder such as Carrie Fisher, Demi Lovato, Russell Brand, Jane Pauley, Mariah Carey, Patti Duke, Jean-Claude Van Damme, Sinead O’Connor, Richard Dreyfuss, Mel Gibson, Michael Douglas, Ted Turner, Brian Wilson, and Frank Sinatra, all very accomplished.

  Unfortunately, when these people feel like a “superhero”, they often stop their meds, and get out of control, worsened by no sleep, and reckless behavior.

  I have reported on bipolar disease at length, and encourage the reader to click on my website www.themedicalnewsreport.com/110 

  It is thought the brain chemoreceptors are triggered giving them the high which makes them feel invincible and firing on all cylinders for days. Dopamine is the most common brain hormone mentioned.

  If a child has this disorder they are often diagnosed as ADHD and have behavior problems.

  Bipolar disorders are classified into 2 groups. It was formerly called manic depression syndrome, but the amount of mania and depression can vary greatly. Most people will never see the depressive phase, because they tend to isolate, and only are around people when they are manic.

Bipolar I—is the classic syndrome with at least 1 manic episode, which may precede or follow a depressive episode. Psychoses may be triggered by a manic episode with breaks from reality. These episodes of mania are severe and dangerous.

Bipolar II—has at least one major depressive episode and at least one hypomanic* episode, but never a manic episode. Depression lasts longer causing severe impairment.

*hypomanic implies a milder episode of mania with the same symptoms of mania, but not causing problems with work, school, and social activities, as well as relationship difficulties.

  The symptoms of mania are acting abnormally upbeat, jumpy, or having “wired behavior, increased energy, agitation, an exaggerated sense of well being and self confidence, a decreased need for sleep, unusual talkativeness, racing thoughts, easily distracted, poor decision making, and risky behavior (buying sprees, sexual risks, making foolish investments).

  The depression symptoms include feeling sad, empty, hopeless, tearful, irritable, loss of interest or feeling no pleasure, with significant weight changes (up or down), insomnia, or sleeping too much, slowed behavior (or restlessness), fatigue, worthlessness, guilt, difficulty concentrating, indecisiveness, suicidal thoughts.

   Severe mood swings are frequent in children. It is difficult to diagnose in children, being confused with ADHD. School difficulty will be present and getting along with their peers can be severe. The LBGTQ+ community is being diagnosed with this disorder often.  

  When life gets in the way of these patients and creates difficulties in families, it is time to seek help. Anyone mentioning suicide needs immediate help, and the patient does not need to be alone. Call the Suicide Help Line at 1-800-273-HELP (8255) or call 911.

  This disorder is more common in families. Periods of stress can initiate a severe episode (death of a relative, loss of a job, financial distress, etc.). Drugs and alcohol are easily abused and mask the real diagnosis plus bringing the episodes on.

  These patients suffer from anxiety, eating disorder, ADHD, and physical health issues, which can be the reason for a doctor visit. The above symptoms need to be asked, because the patients will minimize them.

  Treatments include medications with psychotherapy for monitoring.

1. Mood stabilizers—to control the manic phase include lithium, Depakene, Depakote, Tegretol, and Lamictal.

2. Antipsychotics—include Zyprexa, Seroquel, Ability, Geodon, Latuda, and Saphris.

3. Antidepressants may be necessary in the depressive phase including Symbyax (combination of fluoxetine and olanzapine).

4. Anti-anxiety medications—benzodiazopines can help with the anxiety and sleeplessness, but should be used used on a short term basis. Also Medicare will require a special preauthorization to prescribe narcotics in a person who has a known prescription of benzodiazepines (Valium, Librium, Xanax, Klonopin, etc.). Taking both can increase the risk of overdose.

  Finding the correct medication is one of the most difficult management issues, added to just keeping them on their medications. Side effects of these medications can be a problem, and the corredt dosage is a challenge. Suicidal issues are a concern.

  Lithium, a mood stabilizer, has been reported to be very effective in protecting against suicide. Suicide risk peaks at 45-65 years of age. Lithium may also decrease the risk of cardiovascular disease in these patients. Many psychiatrists agree that lithium is the first line of defense.

  Maintaining patients on lithium is difficult because they feel they cured, and stop their medication. Side effects include dry mouth, urinary difficulty, shakiness, confusion, memory difficulties, and gradual weight gain. These are all manageable and may be temporary. However, they may discourage patients from continuing.

  Fortunately, there is now an injectable form of Lithium, which raises the chances of patients not skipping or forgetting doses. But the benefit of stabilizing emotions and coping ability is a must in bipolar patients. Drug interactions are another factor and need to managed, as the list is quite long, as found in the Mayo Clinic website www.mayoclinic.org

  As in many psychoactive medications, it may take a few weeks for the full effect to be felt, so encouraging patients to expect this and not stop takng it because they think it isn’t working.

  Resistant cases may require ECT (shock therapy).

  Support groups are helpful, and psychotherapy to encourage maintaining intake of their medications is critical and to monitor the levels of manic and depressive behaviors.

  These patients need close monitoring to be sure they are taking their medication, or the consequences can be severe progressing into psychotic behavior.

  Many bipolar patients have substance abuse problems as well, and in case of dangerous behavior may require hospitalization.

  Day treatment programs are helpful, and avoidance of drugs and alcohol are a must. Managing bipolar in the face of these substances makes treatment very difficult.

Mayo Clinic; www.thebipolarcenter.com

3. Celebrities with unusual disorders-part 1 Terry Bradshaw (bladder and merkel cell skin carcinoma; Celine Dion( stiff person syndrome); Alan Jackson(Charcot-Marie-Toothe disease; Bruce Willis(frontotemporal dementia)

  There are a lot of medical disorders that are often rare enough not to deserve a report by itself, but when a celebrity develops it, the interest rises. I will report on a series of celebrities that have diseases that will be quite interesting.

1a- Terry Bradshaw—former Steelers All Pro Quarterback-1970-1983, and now Fox Sports color analyst for NFL games; Cable TV show, etc. Terry and his brother own the golf course right next door to where I live in Bradenton, Florida (Stoney Brook).

Terry has had 2 recent bouts with cancer—bladder cancer and a rare kind of skin cancer on the neck-Merkel Cell Carcinoma.

Bladder Cancer(urothelial carcinoma)

  He was diagnosed with bladder cancer and was treated with surgery at Yale Medical Center with a partial bladder resection. The American Cancer Society has an excellent site for this and any cancer www.cancr.org

  The bladder has a thick lining with significant musculature, which keeps the cancer from breaking through, but still requires much more aggressive treatment because of the chances of recurrence. Note the staging depends on the depth of the invasive cancer (see below).

Bladder cancer is not very common (#6 most common cancer), but still affects over 82,000 Americans annually with over 62,000 men. Staging will be discussed below.

  It is usually a more aggressive type of cancer and can grow quickly and even spread to nearby structures (ureters, prostate, vagina, or into the pelvis. However, it is not uncommon to grow for a year before it is discovered, especially since the symptoms can occur with simple infection. Over 16,000 die each year, but the rates of incidence and cure are improving, if as usual, the cancer is caught early.

  Warning signs of bladder cancer include blood in the urine, pain or burning during urination, frequent urination even during sleep, urgency without being able to empty the bladder, and lower back pain.

  Bladder cancer is the 4^th most common cancer in men. 9 out 10 are over the age of 55, with the average of 77 at the time of diagnosis.

Risk factors

  Age, family history, being overweight, and smoking (most important factor), are all risk factors. Smoking causes half of the cases. Industrial chemical (benzidine, beta-naphthylamine, organic chemicals in rubber, leather, textiles, paint, hair dyes, diesel fumes.

  The diabetic medication, Actos, has been linked to bladder cancer. arsenic in drinking water, and people who do not drink enough fluid and have concentrated urine are all at risk. Whites are twice as likely as any other race to develop bladder cancer. A few parasites in some third world countries are linked.

  It is unclear why people who have chronic urinary tract infections, kidney stones, and those with long standing indwelling urinary catheters can predispose to bladder cancer.

  Congenital defects (at birth, there is a connection to the belly button that disappears, but the urachus can persist (from the umbilicus) and create cancer in it (I have friend who experienced it).

GST and NAT gene mutations in families carry a higher risk. And a small number of people have a higher risk of developing a retinoblastoma of the eye in infants, Cowden’s syndrome (that increases a risk of breast and thyroid cancer) that has PTEN gene. Lynch Syndrome (hereditary familial polyposis and colorectal cancer). When genetic tests are performed, these genes will usually be looked for, as Lynch Syndrome is one of the most common genetic cancers.

  Bladder cancer starts usually on the surface of the bladder wall, and bleed early, so anyone with blood in their urine should have a cystoscopy to rule it out. A simple urine test always checks for blood, so many cancers can be diagnosed early without any symptoms. Urine cytology might demonstrate cancer cells, which might show specific tumor markers.

Diagnosis

  A simple look in the bladder with a cystoscope will visualize the entire lining of the bladder including where the ureters enter. A view of the transurethral prostate will also be seen. Here is a view of a bladder cancer spreading along the surface of the lining. The wire in the below photo is electrical and can cut the tumor out or biopsy it.

Treatment:

Surgical management usually starts with the transurethral cystoscopic removal of one or more areas of tumor, and a second procedure may be performed to assure the area is free of cancer.

  A rigid scope may be necessary in many cases for better removal of the cancer, to stop bleeding with an electric cautery or a laser.

  Staging requires a CT scan, or MRI, while the PET looks for spread, the bone scan for bone metastasis, and chest X-ray to the luns.

  The grade of the cancer will also determine therapy.

  Stage III cancers (see above drawing) require complete cystectomy and the tissues around it. A radical procedure includes removal of the prostate, seminal vesicles, uterus, fallopian tubes, ovaries, the anterior vaginal wall, and uterus.

  If the bladder is removed, reconstruction of a bladder with a piece of bowel can be use and attached to the ureters and urethra.

  Stage III cancers (see above drawing) require complete cystectomy and the tissues around it. A radical procedure includes removal of the prostate, seminal vesicles, uterus, fallopian tubes, ovaries, the anterior vaginal wall, and uterus.

  If the bladder is removed, reconstruction of a bladder with a piece of bowel can be use and attached to the ureters and urethra.

For very early cancers, a liquid cancer drug may be instilled directly into the bladder where it can kill cancer cells on the lining’s surface.

  Chemotherapy may be put directly in the bladder prior to bladder removal, depending on the extent of the surgery. It also may be used to prevent recurrence or progression of a tumor. It may also be used systemically if spread is present or might be microscopically spread because of a high grade aggressive tumor. 

  Certain chemotherapy agents can be heated and instilled into the bladder to treat the cancer (mitomycin, gemcitabine, valrubicin). 

  Radiation therapy may be necessary in later stages.

  Immunotherapy is a common treatment for early cancers as well using BCG—Bacillus Calmette-Guerin, a similar bacteria to the tuberculosis bacteria. It is instilled directly into the bladder for small bladder cancers that have not grown into the deeper layers of the bladder wall.

  There are systemic immunotherapeutic agents that may be recommended for advanced cancers.

  Targeted therapy drugs may be an option for advanced cancers.

  Gene Therapy is a newer treatment and uses a virus which contains a gene that makes interferon-alpha-2b (Intron, Adstiladrin). The interferon stimulates the body’s immune sysem to kill the cancer cells.

  5 year survival rate is 77% according to Mayo Clinic, but if very early, 90% and if localized but into the muscle slightly-70%.

Follow up (survivorship issues)

  Because smoking is so common in these patient’s history, there are several other cancers they will be more likely to develop in the future, therefore, close surveillance over the years is very important to be sure there is no recurrence in the bladder or separate second cancer somewhere else in the bladder. Other cancers at increased risk include lung (most common, accounts for 1 in 4), pancreas, larynx, esophagus, vaginal, prostate, rectal, skin cancer, and acute myeloid leukemia.

American Cancer Sociey, Mayo Clinic

Merkel Cell Carcinoma of the skin (Terry Bradshaw’s second cancer in a year)

  Mr. Bradshaw also developed a rare skin cancer, Merkel cell carcinoma

These cancers (also called neuroendocrine carcinoma) appear as a small flesh colored nodular mass, and tend to grow rapidly from the deep layer of the skin, and are painless. They can metastasize early to lymph nodes, lungs, liver, bones, and brain.

  As they grow, they may turn red or even blue. Any mass suddenly appearing on the skin usually in the head, face, and neck (Terry’s was on his neck skin ) and should be biopsied and removed quickly. This rare skin cancer (20,000 a year), are much more aggressive than the most common types of skin cancer (melanoma can be aggressive too).

  Merkel cells are attached to the nerves that give sensation to the skin. Recently, a virus (polyomavirus) has been found on the surfaces of patient’s skin. Other types are dermatofibrosarcoma, Kaposi’s sarcoma (in AIDS), microcystic adnexal carcinoma), sebaceous carcinoma (from oil glands), and nonmammary Paget’s

  1 in 5 Americans will develop some type of skin cancer in their life, especially in lighter skinned people who are in the sun a lot. Basal cell is the most common, Squamous second, and melanoma third. 9500 Americans will be diagnosed with skin cancer daily.

Risk Factors

  Sun exposure and poor immunity are the risk factors, including older age, light skin, previous other types of skin cancer (squamous or basal cell), and since this tumor occurred after Terry’s bladder cancer was removed, the physical stress of treating the bladder cancer may have played a role. He also could have had some chemo treatments, which drop the immune system, and predispose for skin cancers to develop. Patients that are immunosuppressed should avoid the sun.

  The risk of spread to lymph nodes and other parts of the body is of great concern, therefore PET scans would be performed to search for silent spread.

Treatment

  Surgical excision is necessary (perhaps Moh’s technique), and if suspected, a sentinel node biopsy may be recommended, which is the likeliest node to spread to first. Dye is injected around the tumor and after hours or even a day, the neck is opened to see where the dye went to and that node(s) are removed to examine for microscopic spread. If there is, a more aggressive removal of those nodes in that chain are performed, something called a radical neck dissection (which I performed all my career in head and cancer patients).

  Radiation therapy may be performed if there is any spread to one side of the neck, as the other side of the neck and mediastinum (middle of the chest where lymph nodes will potentially have spread) are at risk.

  Immunotherapy and chemotherapy may be considered in selected cases.

  This spread is highly unusual for other types of skin cancer except melanoma.

  The 5 year survival rate is 78% if localized, but is only 52% if spread.

American Cancer Society; Mayo Clinic; Moffitt Cancer Center

 1b—Celine Dion—Canadian-born very famous singer has cancelled her world tour because of a rare disease called Stiff Person Syndrome. Since it is progressive, it is doubtful she will continue her career. It is manageable with medication, but is progressive and incurable.

Fewer than 5,000 people have this diagnosis in the U.S., and it is twice as common in women.

  One of the greatest singers ever has developed a progressive  neuromuscular disorder from a central nervous system dysfunction. This disease is characterized with stiffness and spasms, mainly in the trunk and abdomen with rigidity and loss of smooth motion of these muscle groups.

  How Celine Dion is specifically affected is not printed, but, I would assume, not having command of her abdominal muscles would greatly affect her vocal abilities. She has stated she is having trouble walking and using her vocal cords to talk and sing. She is undergoing intensive physical therapy, speech therapy, and I am sure meditation, and methods to cope. She is very hopeful to return to the stage, but only time will tell.

  Other symptoms include anxiety, excessive sweating, and hypothyroidism. They may have a “startle syndrome”, over responding to sounds or touch.

These patients are often misdiagnosed as having Parkinsons, multiple sclerosis, fibromyalgia, and other neuromuscular disorders.

  There are 3 types described:

a—Autoimmune—these patients usually type 1 diabetes, vitiligo, thyroiditis, and pernicious anemia develop antibodies against glutamic acid decarboxylase (GAD), an enzyme involved in the production of GABA (gamma aminobutyric acid), a neurotransmitter, which are chemicals that influence electrical impulses at the neuromuscular junction of nerves and muscles.

b--Paraneoplastic (associated with certain cancer, especially breast, but also lung, kidney, thyroid, and Hodgkins). Antibodies are secreted by a small percent of these patients, and represent only 1-2% of the total number of cases. There are many tumors that secrete certain chemicals, even hormones, that can affect the body and often aid in the diagnosis of the cancer.

c—Idiopathic—means there are no underlying conditions to point to.

Diagnosis—Diazepam (Valium) is given to observe relaxation of the musculature. Elevated levels of GAD(glutamic acid decarboxylase), and results of an EMG (electromyogram), which measures the electrical activity of the nerves and muscles are also tests used to confirm the diagnosis.

Treatment

  The use of valium (the drug of choice), baclofen, IV immunoglobulin, and if necessary the use of retuximab (Retuxin) often used in non-Hodgkins Lymphoma, or plasma exchange, removing the antibodies from the blood.

Msdmanuals.com; hopkinsmedicine.org   

1c--Alan Jackson—Charcot-Marie-Toothe disease

Alan Jackson is having to deal with a rare hereditary disease that causes sensory and motor nerve damage in peripheral nerves in extremities with weakness, hammer toes, and loss of sensation of the lower legs.

  About 200,000 in the U.S. suffer from this disease. The brain is not involved, rather the nerves that come from the brain to the extremities, and usually starts in the teens or young adulthood, although, Alan Jackson is middle age. Curled toes and high arches occur due to weakness in the feet. There can be difficulty in walking, tripping, and balance.

  The disease comes on very slowly and most patients don’t even know they have a problem for years. It rarely affects life expectancy, but for a musical performer, Jackson could have problems performing on stage. Ultimately the hands can be involved and then playing the guitar would become impossible.

  Dr. Charcot-Marie-Toothe, a French doctor named the disorder.

  There are 4 types of this disease depending on what part of the nerve is involved. Many other neurological diseases can mimic this disease, even multiple sclerosis, ALS, et.

A genetic disease

  Most of these diseases are autosomal dominant. If a parent has this disease, there will be a 50% chance the children will get the disease.

  Others can have autosomal recessive genes and won’t have the disease unless both parents are affected. X-linked inheritance in type 4 disease means the genetic mutation is on the X chromosome and a more severe disease.

  Genetic counseling is importnt to discover the type of genetic abnormality.

  There is no treatment, and some will wind up in a wheel chair, but with good physical therapy and stretching of atophie muscles, a near normal life can be enjoyed. I pray Alan Jackson can continue to perform in some capacity.

Medlineplus.gov

1d--Bruce Willis—frontotemporal dementia

I recently reported on Bruce Willis when he was diagnosed with aphasia. It was not clear at that time that his expressive aphasia, which made it difficult for him to understand words and express what he wanted to communicate, was only the beginning of a more serious form of dementia—frontotemporal dementia.

  Dementia can have different presentations depending on what portion of the brain is involved.

  Alzheimer’s is the most common affecting small areas in the midbrain saturated with specific proteins tau and amyloid. Cognitive issues dominate this disease, and I have reported on it several times.

  Vascular dementia, somewhat rare, occurs after a stroke usually which intereferes with executive functioning, planning, judgement, etc., and may have Parkinsonoian symptoms.

Frontotemporal dementia affects the frontal (left drawing) and anterior temporal lobes (arrow right drawing) of the brain, and affect the personality, behavior, and language. The left frontal lobe affects speech the most. These patients are impulsive, socially inappropriate, and at time indifferent.

  This disease could be initially diagnosed as a psychiatric disease or Alzheimer’s, but occurs at an earlier age than Alzheimer’s beginning in the 40s with 60% between ages 45-64. It accounts for 10-20% of dementia.

  Episodes of behavioral abnormalities are common. The average survival time is 7.5 years before a diagnosis is made. 40% have a familial origin, with mutations in more than 20 genes that have been linked to the development of this type of dementia.

  Bruce had trouble understanding words and had expressive aphasia, which would have made it difficult to remember and understand his lines and saying them correctly, and had to be constantly reminded of the few lines he was going to say in a movie.

  In later disease, motor disorders may occur with rigidity similar to Parkinson’s disease, tremor, and twitching of muscles, with weakness, falls, and walking problems.

  In frontotemporal dementia, those parts of the brain begin to shrink. Newer research has foiund that there shared genetic pathways in patients with ALS.

  In summary, it is pretty clear that all patients may be very difficult to diagnose these types of dementia and will be referred to a psychiatrist with symptoms and as the disease progresses, or a doctor is very sharp at picking up subtle symptoms, his diagnosis may be delayed.

  Sadly, memory care, and keeping the mind going is the mainstay of therapy, as there are no meds available.  Symptoms that make the patient difficult to control require psychiatric drugs, but they are only for symptoms and there ae no drugs to slow down or prevent progression.

  Families will need support to cope with these patients, and they will be better off at home til too unruly, as the facilities are very expensive and not covered by insurance usually until they qualify for Medicaid. Speech and physical therapy are essential.

Mayo Clinic; Medpage Today, Feb. 23, 2023

Part 2, next month, will continue with other celebrities with unusual diseases, which allows me to highlight diseases otherwise not reported on—Toby Keith (stomach cancer), Venus Williams (lupus), and Jimmy Kimmel (narcolepsy).

4. Child abuse and its consequences in adulthood—Part 4 of mental disorders of Youth

This country is suffering from a rise in youth deaths from overdoses and suicides, and parents need to wake up. They have also been mentally injured by the misguided strategies of the pandemic, from loss of companionship, isolation, more time on social media, and they forgot how to relate and treat each other face to face.

  1 in 3 highschool girls consider committing suicide, according to the CDC, and note that teenagers are facing the highest degree of sadness and sexual violence in a decade. Parents must be extremely sensitive to their child’s behavior, school grades, friends, and social media watching. It is a prent’s responsibility, and obviously a lot of parents get failing grades. Medscape Medical News, March 13, 2023

  Even with 1,350 child therapists and 700,000 social workers, more mental health experts are needed to meet the demand. So many teenagers do not seek care and carry their childhood abuse into their adulthood. Screening for these traumas need to be increased by pediatricians and primary care professionals, and as stated the parents.

  Some were stuck in a home that were abusive from a family member---sexual abuse, beatings, verbal abuse, neglect, humiliation, and denigration…all destroying their self esteem.

  The scars in childhood often keep these children from disclosing their traumas, and carry them into adulthood. Many are unable to maintain a normal functional relationship as an adult. They are set up for psychologic disorders throughout their life. Anxiety and borderline personality disorders are 2 of the most common.

Fatherless homes

  Parents who are separated from each other and have no time for their children suffer the consequences of neglect, and expecting school and professionals to do their job. This is child abuse. Alcoholism, substance abusive parents, and mental disorders have major influences on children.

  If someone wants to have children, part of the responsibility should be to have active parents, with a father being a significant part of raising that child. Without it, look what has happened to our youth?

  At the University of Virginia found that adverse childhood experiences, especially sexual exploitation, increase the risk of cancer diagnoses, a higher rate of sexually transmitted diseases, and risky behavior. Even teen pregnancy is linked.

  The results of not being able to maintain stable adult relationships create numerous hardships in adulthood.

  There is research that suggests the brain circuitry is changes altering the response to stress, raising the emotional response to threat. Parental love can protect a child from abnormal responses to toxic stress. Physical contact can nurture a sense of self and elevation of esteem. Without it, these can be lost.

  There are numerous somatic health issues that are common, according to the National Institutes of Health. Nightmares, back pain, eating binges, diarrhea, constipation (IBS), sleep difficulties, and headaches are the most common. Women develop reproductive health issues such as pelvic and genital pain, vaginal discharge, and eventually chronic fatigue syndrome (now called central hypersensitivity syndrome).

  Trust issues, feeling safe, and secure are common issues as well. All of these issues were tested greatly during the pandemic, and continues.

  As adults, memories are often forgot, and sent deep into the psyche. Getting these people to discuss their childhood experiences are very difficult. Depression makes it more difficult to access these childhood experiences.

  Other personality disorders that can occur are dissociative identity disorders (multiple personalities). Borderline personality disorders are expressed as impulsiveness, self image difficulty, self harm, anger, anxiety, dissociation, feeling empty, often in conflict and fighting with those surrounding them, paranoia, depression, identity crises, and even psychotic symptoms such as hearing voices when stressed. 1.8% of the population suffer from this disorder.

  Some of these children as adults will abuse their children. Growing up hating yourself can reflect on their kids.

  Spousal abuse was increased during the pandemic, and for those who were abused as children, they were particularly affected due to the stress created by isolation, lockdown, loss of jobs, and food insecurities. Centers for spousal abuse were affected too, as they were not open as usual.

  We all must admit the management of the pandemic has affected every aspect of our lives. That severe stress that occurred early in the pandemic are now contributing to more physical and mental disorders mentioned above.

JAMA Network, March 14, 2023

Southern California Sunrise Recovery Center, June 9, 2021

  Counseling as soon as possible as a teen is best, but never too late. Therapy for those who abuse others is also very important, connecting all the past traumas to the current personality issues.

  Rebuilding self esteem is the goal of therapy. Group therapy is helpful, seeking religious help, learning to trust again, and seeking help to gain meaningful relationships are all so very important.

  There are many forms of psychotherapy that will help, and seeking consultation for the right therapy is critical in the beginning. For those who abuse must deal with their own abusive history, and accept responsibility for abusive behavior and recognizing abuse is a choice. Changing response to stress and anger is key in recovery. Substance abuse is very common problem with these patients, because of the deep seated guilt they have.

Goodtherapy.org is an excellent site to access. It is a long term issue that took years to occur and it will take years to control and master it.

Psychology Today, stepupformentalhealth.org

 5.FDA needs to do better!

 The FDA and the CDC have had “egg on their faces” for sometime, but with the pandemic, several flaws have become more obvious, and not admitting that they are making educated guesses half the time, is a terrible shame. Being honest has become passe’, and now politics seem to rule our healthcare too.

  I have stated that as long as the feds are in control of the FDA and the CDC, there will be political contamination, not to mention the worst contamination (Big Pharma) when the feds are owned by Big Pharma, since that group is the largest lobbyists in the country for campaign contributions to congress and those with influence in the White House. Now we know that academic medicine has joined the group “Big Medicine-Big Government-Big Pharma” aided greatly by the media, big tech, the teacher’s unions, and all at the peril of the American citizen.

  We have witnessed half truths, guesses, and political decisions time and time again with statements that were questionable to begin with, but were allowed, only to have later data refuting their reports. We must make decisions based on sound peer reviewed data, that is reproducible.

  Since the emergency use authorization act—the accelerated approval program, The FDA has been under pressure to quickly approve drugs and devices with little scientific data. 71% of cancer drugs used other research they were not involved with (surrogate end points).

  Since this decade, this approval process is being used for many other drugs, and often without majority approval from the advisory committee responsible for analyzing data and making the decision to approve or disapprove. The higher ups are making the approvals, and it stinks of financial contamination by Big Pharma and Big Government. There have been drugs approved by the FDA that was disapproved by this advisory committee, and some members have resigned.

  A recent drug, Parkinson’s anti-amyloid plaque med, was approved with minimal value for cognitive decline reduction. These drugs are very expensive, and Big Pharma wins every time, and the government has an agreement that prevents them from negotiating drug costs for Medicare.

  The fact that Lilly was willing to lower insulin prices for Medicare recipients, had to involve some “under the table maneuvering”.  

The accelerated FDA approval process being abused

  The accelerated approval process for medications and medical devices is being abused. The FDA must be an independent organization without contamination by Big Pharma, Big Medicine, and Big Government.

  When a drug is discovered that has no other alternative, these medications get approved often with little data, especially the safety of these drugs (and vaccines).

  Some of the top advisors have admitted they are guessing at answers with this pandemic, and now they are being asked to decide about an annual COVID vaccine that will be able to curtail the virus at least enough to prevent more serious disease and protect those who are medically vulnerable. Expert infectious disease doctors like Dr. Paul Offit, Stanford, has been one of the main dissenters on the advisory board for the FDA that decides on vaccines.

  The FDA approved with reservation a hormonal treatment, Makena, hydroxyprogesterone caproate injection in 2011, to reduce preterm birth, however, with the accelerated pathway, even though there had been a clinical study that did not show benefit.

  The FDA proposed it be withdrawn in 2020. However, with the power of the drug company their drug continued to be used while waiting for a requested hearing on the decision. It took 3 years for that to happen, and they have now withdrawn their approval, and it cannot be distributed interstate use, but some doctors are still using it.

  Risks of the drug include blood clots, emboli, allergic reactions, interference with blood sugar, and fluid retention.

  This is our FDA!!! This is the power of Big Pharma. Makena approved in 2011 with serious concerns and now in 2023, it is disapproved, and some doctors will continue to use it, because there is no alternative. Medscape, April 6,2023

 Here is a statement from the JAMA journal:

  Admittedly, when a crisis is at hand, some decisions need to be made rapidly, even when there is little data, but admit it that is a hurried decision, and request follow up data, but years can pass, before the information is made available.

  2 administrations have been counseled by “experts” (Fauci, inc.) and Big Pharma that have repeatedly lied about the virus, its origin, gain of function funding, side effects of the vaccine, value of the vaccine, need for boosters, length of immunity, the omission of natural immunity, value of treatments, and the consequences the of isolation, masking, school and business closure and other measures that have created a physical and mental disaster in our country…even a spiritual one.

  The political contamination of the current administration and its obvious push with the socialist/Marxist movement has never been so apparent while flooding our country with illegals and allowing the drug crisis, the cartels, and human trafficking to go untouched.

  Clinicians need better education about brand new drugs and honest assessments of their value. Don’t expect a pharmaceutical representative to tell the doctor something controversial.

Much of the research is performed by doctors getting financial benefits from Big Pharma, while the medical centers and medical universities receive major funding for research and expansion of their facilities.

  Most of the research done by doctors in major medical centers have been heavily involved financially with these pharmaceutical companies, and the companies have funded the research in many cases. This makes much of this kind of research suspect for bias and fraud. The journals are full of these kinds of published reports.

  CMS (Centers for Medicare Services) has much too much control of the actions of these organization. It is never mentioned (except in medical journal reports) how often the advisory panels of doctors to approve drugs, are split in their decisions to approve.

The FDA has little control

  The CEO of the CDC resigned (Dr. Robert Redfield), after he clashed with the decisions by the COVID Advisory Group, headed by Dr. Fauci. Now the CDC has been given a gag order not to talk to the public. When was the last time you heard from the head of the CDC or FDA? Now retired, Redfield has now, under oath, exposed some of the internal disagreements about the origin of the virus, and many maneuvers instigated by the administration (lockdowns, schools closed, isolation unnecessarily, and and mandates).

  Now that the information about COVID is being declassified, it was reported that the FDA took just 5 weeks to give full approval to Pfizer and Moderna for their COVID vaccines, when it normally take more than a year to advance a drug given emergency use authorization to standard full authorization. Many experts are not happy with the FDA for streamlining this, right before the administration declared a mandate of the vaccine on the military. Such obvious political contamination!

  Judges have blocked the FDA approval of Mifeprex, the moring after pill in Texas. This pill is used for more abortions than any other method. This occurred while in the State of Washington, the U.S. District Court that prevents the FDA from altering the status of the availability of the generic version (mifeprestone). These rulings wind up going to the U.S. Supreme Court. What is at stake is dispensing the generic drug by mail.

  These rulings are creating such a political divide and will make abortion one of the top reasons for voting liberal or conservative, when there should be compromise. Conservatives must decide how bad they want to run the country, and when the morning after pill is the rule, voting becomes very clear, regardless of all the other major political issues facing our country.

  Strict religious ideologies in conservatives create little room for compromise, like considering a heart beat present, rape, incest, and a mother’s health, 15 weeks, etc. Principles are one thing, but winning presidential and congressional races requires discussion and compromise.

  Conservatives underestimated the magnitude of this issue in the midterms, and cost the Republicans major loss of majorities. 

Medpage Today, April 8, 2023

  The FDA has chosen to approve laboratory medical tests, without full knowledge about the safety and effectiveness of the tests. This issue has fallen on the CMS unnecessarily. Lawsuits are abounding questioning their authority, which has weakened the decision making by the FDA officials. The FDA has no more authority than the EPA, as both are being controlled by governmental officials through CMS in the case of the FDA.

  This issue created interest in introducing congressional bills to alleviate this flaw in testing. If passed, the requirements will require developers to conduct surveillance of higher risk tests once they are on the market and mandate adverse event reporting by developers. An example would have been the number of people stricken with myocarditis and other serious illnesses from the COVID vaccine.

  In May, 2022, Congress was supposed to incorporate into a Senate bill a user fee re-authorization bill that must be passed every 5 years, to review the FDA’s actions, because it funds a large portion of the FDA activities. Congress, unfortunately, according to an article in Medpage Today, passed a stripped down continuing resolution that left out any provisions on approving laboratory based medical tests, which is a great loss for consumer protection.

Medpage Today, December 9, 2022

  Medicines always have a harm-benefit issue, as any chemical put in the body can have adverse reactions, but when it is deemed much more effective over the potential side effects, the FDA likely will approve it. That means they are expecting a certain small number of people will suffer from that medication or device.

  An example is tamoxifen, an anti-estrogen taken by many premenopausal women with estrogen positive breast cancers. It is known to cause an increase incidence of uterine cancers, not to mention other side effects, and has been controversial since its approval.

  A Korean study found that the risk increases 4.5 X more uterine cancers in those taking tamoxifen than those who don’t and 6X greater chance of developing hyperplasia of the lining of the uterus. This finding was found in those who take it for 5 years and longer.

  If taking tamoxifen, should surveillance of the uterus be more aggressive with D&Cs yearly, or what? Where does the FDA sit on a drug clearly valuable and yet, with newer research the risks are greater than reported before? Should that drug be pulled temporarily while new evidence is analyzed. It doesn’t usually happen…rather the FDA may put out a “black box” caution label in the medication, which patients don’t even know about.

  The American Cancer Society cites a 50% lower risk of another breast cancer in the opposite breast and less recurrence by 30-50%, if tamoxifen is taken. One can see the dilemma in the case of a drug which can save lives and yet cause cancer in the uterus. If taking tamoxifen, should surveillance of the uterus be more aggressive with D&Cs yearly, or what? Where does the FDA sit on a drug clearly valuable and yet, with newer research the risks are greater than reported before? Should that drug be pulled temporarily while new evidence is analyzed. It doesn’t usually happen…rather the FDA may put out a “black box” caution label in the medication, which patients don’t even know about.

  The FDA may approve a drug or medical device, but it always puts the decision on the patient and doctor, where it deserves to be. It also should remind the reader how critical a part is made by the patient when discussing medical issues with their doctors. Today, there is a lot of bias in doctors too, and that is when a second opinion should come.

  The accelerated approval process has suffered as well with poor decision making. There is discussion in Congress to limit the time for such an approval to automatically expire unless the FDA confirms the approval can continue.   

JAMA Network, Dec. 8, 2022 (a viewpoint not a study)

Arthritis drugs cause big trouble too

  One of the major classes of drugs (TNF inhibitors—tumor necrosis factor—tofacitinib (Xeljanz)) to treat rheumatoid arthritis, spondylitis, psoriatic arthritis, juvenile arthritis, and ulcerative colitis is causing more cancers than initially reported, but the FDA only warned of the issue as these drugs multimillion dollar makers for the drug companies. Do you think there was some collaboration between the FDA and Big Pharma? They include Enbrel, Humira, Cimzia, Simponi, and Remicade.

  All the FDA required was a stronger black box statement on the drugs. For Xeljanz, 1 in every 55 patients is expected to develop lymphoma or lung cancer, not to mention higher rates for skin cancers. Are these drugs effective?? Yes!! Are doctors and patients going to stop them?? NO!

  No one says the FDA’s job is easy, but with underfunding, extreme political influence, financial contamination by Big Pharma, lack of long term studies, and fast tracking, the FDA has to trust the data provided, and as it turns out, in the last few years, there has been a significant rise of fraudulent studies.

  This is a good example why any single study should not be trusted, and adequate time must pass for reports to be published on the risk benefits. In a pandemic, there is no time, so political and health expert decisions have to be made when the severity of a disease or disorder is not yet known. Often other countries are allowing it and people go out of country to get it.

  The FDA faces persistent tension between confidence and speed in drug and product approval. Gatekeepers can prolong the approval process, but with the pressure from the Congress to speed up their process, it has led to the FDA to depend more on the drug manufacturer and for the company to voluntarily withdraw a dangerous or ineffective drug. This opens the door to bribes, fraudulent data, and lobbyists contaminating the Congress every day. And they expect a preapproval withdraw pledge. OMG!!

  This recently occurred with Relyvrio for ALS-amyotrophic lateral sclerosis. This drug was approved in the accelerated program and the FDA is depending on the company, Amylx, to voluntarily withdraw the drug if necessary. This “right to try” process started with President Trump, and has created good and bad examples.

  A more recent article from the JAMA Internal Medicine, Feb. 13, 2023, cited that 1 in 10 medicines approved by the FDA did not achieve their main goal. This study found that 210 drugs were approved to treat cancer, Alzheimer’s, and other diseases. Researchers questioned whether the FDA drug approval process lacks transparency about safety and effectiveness. This study included drugs from 2018-2021. 

And we wonder why the FDA is constantly put in an untenable position, and is swayed by political influence.

JAMA Network, Dec. 8, 2022

  The average time of drug approval without emergency use authorization is years. In cases of global crises, our leaders must be trusted, and that is where we have come, with a totally divided country in terms of trust, support, and defense of actions taken.

  Honesty has suffered tremendously, and as we find out all the mismanagement and missteps, wrong actions, and the loss of lives, and $trillion of dollars spent dring the pandemic added to inflation, creating a disastrous economy, untold suffering mentally of our children, and adults, there must be a better way with better leaders.

  The medical journals and national medical organizations, and liberal left have the answer….socialized medicine…..and you think this government can do a better job if they control all of medicine, your personal data, what you hear and read (censorship), who owns the hospitals and doctors, what you get to eat and drive, where you go to school and what your child is taught??

  There is only one hope….independence from political contamination and big dollars from Big Pharma….or is that even possible anymore?????

NEJM, April 6, 2023—Perspective ensuring public trust in an empowered FDA

6. Eldercare crisis

  After the pandemic, we continue to struggle with many weaknesses of our healthcare system, and the caring for our elderly and disabled has shown us who weak.

  The number of staff in nursing homes who were infected was astronomical, and created a shortage from the beginning. Those who were able to work, often had to pull double shifts, and over time, along with the stress of COVID, wearing faulty protective gear, and often longer than was recommended, created an enormous stress, not to mention, that friends and relatives were not allowed in the building, and the patients were isolated like never before.

  Patients died, were transferred to hospitals, ICUs, and many died, not necessarily because of the COVID primarily, but in combination with their underlying medical conditions. Again, no relatives, no friends, and when they died, no funerals for family and friends to grieve.

  Doctors, nurses, and staff, down to the janitors, were stressed to their limits to keep these skilled nursing care facilities as clean as possible. Can you imagine the stress of having linens, etc. clean and beds needing changed often more than daily?

  Burnout became a serious issue, and still is. The staff have moved away from nursing care to different jobs, some quit working all together, and those who got sick decided to stay home to prevent getting sick again. Nursing care has suffered greatly, and patients were neglected, and often died.

  Some nursing facilities have closed because of low staffing, and many are under constant surveillance for breaking rules. It has become a serious issue.

  Sick patients were often sent to these facilities with COVID, which spread the virus even more. Remember what happened in New York?? The governor sent positive sick patients from the hospital straight to the nursing homes spreading COVID rapidly.

  Some elder patients are blessed to have home healthcare, but nursing shortages in that field are also an issue, and have put more pressure on family to care for their elder or disabled relatives. Those in specialty care facilities are feeling the loss of adequate staffing, and it will not get better even with the pandemic essentially over. Nurse once took care of patients, and now techs are.

  Pressure from the government on these facilities has become very strict, as they realize the impact on the patients. Families see it too, when they visit. Getting angry at the staff that is present has created its own problems. Everyone is under stress.

  Rising salaries has only partially helped, as the margin of income is shrinking, and many facilities are closing. This information isn’t making the front page of the newspapers or the 6 o’clock news.

  Delays in diagnoses and treatment of diseases caused many premature deaths. Isolation and shut downs are still being felt.

   Isolation and loneliness are killers. Look what happened during the pandemic. Nothing could be worse than those living by themselves or in nursing facilities.

  There is direct correlation between isolation, lack of social engagement, and reasons for wanting to live, as the the rate of depression, increasing dementia, infectious diseases (especially urinary tract), and pneumonia from being in bed most of the time.

  These issues are severe as the effects of morbid obesity, as pointed out by the NEJM article on isolation and lonliness. Even biologic markers in the blood become abnormal with these issues, predisposing to disease, but will improve with reconnection and social integration.

  Many healthcare providers are suffering from these issues as well, and are part of the burnout of these health experts.

  Below is a very sincere message written by one of our Bible Study members about caring for his 96 year old mother, and can say it much better than I could possibly do. Please read on the next page.  

NEJM, January 23, 2023

This ends the May, 2023 report!

Next month, the June report will include:

1. Celebrities with unusual diseases-Part 2

2. Cancer Screenings lagging

3. OB/Gyn Series—Part 10—menstrual abnormalities and new therapy

4. Oral and Throat cancer update; HPV vaccine

5. The Havana Syndrome

Enjoy the summer, and stay healthy and well, my friends, and be kind to each other! Dr. Sam