The Medical News Report

August, 2019, # 91

Samuel J. LaMonte, M.D., FACS

www.themedicalnewsreport.com

Subjects:

1. Low back surgery—new concepts--Ruptured Lumbar Discs-consequences; Trans-abdominal approach to lumbar disc 

2. Health Fads, Failures, and Fixes

3. Medical Updates—

   a- Measles outbreaks increasing because of non-vaccinations

   b- Can a mammogram be comfortable and accurately  diagnose cancer as well?

    c- Textured breast implants recalled by the FDA because of cancer risk

    d- Gluten present in 30% of restaurant food that is labeled gluten-free

    e- Healthcare costs and our fractured Congress; Big Pharma winning! Ugh!

4. Medicare for all proposal-my opinion!

5. Migraine Headaches--New preventative medication

6. Impulse Control Disorders (differs from OCD)          

IMPORTANT REMINDER!!!! PLEASE READ!!!

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

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

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

Thanks!! Dr. Sam

1. New concepts in low back surgery

   A. Lumbar disc rupture—what happens to the level above a surgical disc procedure compared to using a non-surgical approach? –important news

  This study is big! For years, it was thought by the medical community that performing a lumbar spine laminectomy with fusion would increase the likelihood of deterioration of the vertebrae immediately above that vertebrae, especially the disc, because it allowed the shock waves coming down your spine to accumulate just above a fusion. In fact, in previous reports, I have stated that concern. For a review of lumbar laminectomies with or without a fusion using various techniques, please click on: www.themedicalnewsreport.com #52

  I have had L-4-5 laminectomy with fusion several years ago, but to date, my vertebral disc just above has not deteriorated, and my fusion has caused me no difficulty. Many people are not so lucky. If a disc herniates above a surgical site, it usally occurs within 8-10 years.

  In the journal, Spine, 2018, a randomized controlled 8 year study was reported on this very subject. Because of the concern that disc deterioration just above the fusion occurs fairly frequently (40%), it might be occurring due to the lack of motion in the spine created by the fusion.  Because the fusion was blamed on vertebral disc  deterioration, techniques were developed to replace the disc with a motion-preserving total disc replacement without fusion.

These images above show how bulging discs can press on the spinal nerves and the spinal cord.

  (This drawing on the left shows an artificial disc replacing a herniated disc and a ruptured disc compressing a spinal nerve on the right.

Results of the study

  40% of the nonsurgical group developed herniation and 42% of the total disc replacement group had herniation of the disc immediately above the previous disc surgery. An MRI was used to diagnose these hernations.

  It is clear that surgery is not the only reason these patients herniate another disc.  Other issues must be in play, including more injury and continued progression of aging, arthritis, and genetics.

  A 2014 study in the Spine Journal did this same comparison with surgical fusion vs. non-operative patients with physical therapy alone, and again reporting no difference in the groups regarding eventual outcome of the above vertebral disc.

  The actual pathology in the lumbar vertebrae and disc should determine the choice of treatment for each patient. Narrowing of the space between vertebrae usually starts the process with more and more pressure on the disc until it herniates or collapses.

  Time is always a factor, and regardless of cause about 40% of all these patients with one ruptured disc are going to herniate another disc usually just above the previous herniation.

  What can be done to counter these possibilities as much as possible? Exercise, weight loss, yoga, strength training, acupuncture, stretching, physical therapy, etc. can all give a person a fighting chance. It has helped me immensely. It can help you!

   B. Lumbar Spine Surgery through the abdomen-new innovations

I was invited to Hawaii as a senior in medical school to work in the surgery department of Queen’s Hospital in Honolulu and was privileged to scrub in and learn from Dr. Ralph Cloward, a famous neurosurgeon, who developed the approach to cervical vertebral disc surgery through the front of the neck, using bone grafts for fusion (now titanium cages are used). He also developed the technique for posteror lumbosacral interbody fusion. That was in 1968, and now most cervical spine surgery is performed through that approach thanks to Dr. Cloward’s innovations. He inspired me to apply and was accepted into a neurosurgical residency (I later switched to ENT-Facial Plastic surgery). 

Option for a new surgical approach—trans-abdominal

  In the past couple of years, the lumbar spine is now being approached through an abdominal incision in selected cases. (more direct access to the disc).

  This is particularly valuable for disc surgery when the vertebrae do not require fusion. As in any new innovation, there are a few major centers in the country that have perfected this approach usually combining the talents of a spine surgeon and a general vascular surgeon. Patients do have to overcome the abdominal incision pain, and potentially there is a greater risk of major vascular injury.

  I have discussed low back surgery in previous reports; click on this report: www.themedicalnewsreport.com #23 and #52

The drawing above demonstrates that the vertebral body actually points anteriorly (toward the abdomen). For this approach, the spine must be fairly stable, and only one level can be operated on.

  There are options to address the removed disc—use a prosthetic disc (just discussed above) or an autograft of bone (irradiated cadaver bone) surrounded by a metal cage. This is at the discretion of the surgeon.

Technique of trans-abdominal lumbar disc surgery

  When approaching through the abdomen, two surgeons are required—an orthopedic or neurosurgeon and a general vascular surgeon.

  The general vascular surgeon makes an incision in the middle of the abdomen between the rectus abdominus muscles. The abdomen is lined with a dense tissue called the peritoneum, which contains all the abdominal contents. The dissection can either stay outside the peritoneum separating it from the inside of the abdomen and separating it off the vertebrae or the approach can be straight through the middle f the abdominal contents. The main danger is damage to major blood vessels, as the vessels must be moved to one side for surgery(below drawings).

  The alternative approach would be to proceed directly through the abdomen to the vertebrae. That approach requires an incision, moving the intestines aside to expose   the posterior peritoneum (retroperitoneum) as seen in the  drawings below to expose the vertebrae.  

This anterior approach can be combined with a posterior (back) approach for more aggressive fusion with a spine that is unstable in very selected cases.

  An additional complication for males, if the L-5-S1 vertebrae is to be operated, is retrograde ejaculation can occur and the sperm goes into the bladder instead of out the penis. Small nerves can be damaged that control a small valve that prevents the sperm from projecting out the penis. These nerves are rarely injured, but it is a potential risk. Orgasm and potency are not affected. This is not an issue for L-4-5 and above.

  The other major concern is a non-union of the boney fusion. This is more likely for patients with previous back surgery, smokers, overweight patients, when more than one level requires fusion, or the patient has had radiation for cancer in that part of the body, or patients with opsteoporosis. Yur surgeon may suggest this approach, but long term studies are still nt available to prove this makes any difference long term. But theoretically it is an improvement in selected cases. 

  For more information and videos,  go to www.spine-health.com

2.  Health Fads, Failures, and Fixes

   There was an interesting article published by AARP (American Association for Retired People, June, 2018) in their handout to members. It was a good discussion with reasonable references. When it comes to information on the value of vitamins, supplements, and herbs, organic foods, and diets, there is so much misinformation,  unsubstantiated claims (no true good research), and  testimonials that is making these industries $billions.

  These “health blogs” on internet sites are full of conspiracy theories, miraculous claims, ancient Chinese secrets, product endorsement by celebrities, and “amazing cures”. Even Dr. Oz has been fighting these companies who have misused his photo with false claims.

  And yet we are all guilty of buying these products or incorporating them into our daily lives giving us a false sense of control for a lot of money (and never telling our doctors we take them).

Fads, Failures, Fixes

A. For a stronger heart!

1. Fad--coconut oil—no miracle at all, in fact, there are no known scientific benefits and coconut oil is 82% saturated fat (30% more than butter). The American Heart Association recommends avoiding it. It is a great lubricant for the skin as a salve, but not good for your vessels.

2. Failures—Antioxidant supplements—Eating fruits and vegetables can potentially reduce the risk of heart attacks, in part because of its antioxidant content, which can reverse inflammation and plaque in arteries. However, research shows that in pill form, vitamins A, C, and E, and beta-carotene have no heart benefit. In high doses, they can harm the heart.

  Omega-3 fish oil supplements (over the counter) do not lower heart attack risk in people without heart disease, because many brands do not have adequate amounts of the proper types of fatty acids (need 4000 mg), and the products are very questionable.

  If you need Omega-3s (EPA and DHA most important), you must have prescription-strength supplements (Vascepta or Lovaza, 4000 mg per day to control high triglycerides). In patients with heart disease, they may be quite valuable if the triglyceride fats are elevated. People with heart disease from cholesterol need statins. A healthy low fat diet, exercise, less stress, weight management, control of diabetes all must be followed to get maximum protective benefit. If a person has no heart disease, even aspirin is of no value based on the latest studies. Talk to your doctor about the need!

3. Fixes—A handful of nuts a day has been proven to reduce heart attack by 30% when added to a Mediterranean diet (not by itself). Adding nuts to a poor diet just adds more calories and causes weight gain.

B. For a happy stomach

1. Fad--Gluten-free diet (without Celiac disease)—A U.S. survey reported that 30% of adults are avoiding gluten unnecessarily. Without gluten (fiber and vitamins), a 2017 study showed an increased risk for heart disease. Cereals and grains are an important part of a heart healthy diet.

2. Failure—Colon cleanse—Liquid enemas to detoxify the body is not only worthless, but can be dangerous including painful, and can cause potentially fatal electrolyte imbalance, renal failure, and perforations of the colon. Colon bacteria are part of the immune system, and for some GI diseases, there is a change in the bacterial flora may need to be reversed with probiotics and even fecal transplants in resistant cases.

  Prebiotic supplements (as opposed to probiotic supplements) are a poor substitute for foods such as garlic, onions, asparagus, bananas, artichokes, and sauerkraut.

  High quality probiotics may be valuable especially when taking antibiotics or for patients with chronic intestinal disease, such as Crohn’s, Celiac, ulcerative colitis, or irritable bowel disease. There are several over the counter probiotics that are of little value. Talk to a gastroenterologist (or an experienced primary care doctor) about the actual strains of bacteria that are valuable.

  Foods containing bacteria are far better (fermented foods like yogurt, sauerkraut, etc.) than any pill supplement.  

3. Fixes—Peppermint oil (menthol is the main active ingredient)—is effective in treating irritable bowel syndrome.

  Fecal transplants(healthy bacteria from feces inserted in the colon or by mouth)—this is a recognized treatment for certain patients with inflammatory bowel diseases, lupus, and diabetes, all known to have altered bowel bacteria, and patients infected with Clostridia difficule (C.diff), which occurs after taking antibiotics.

C. Smoother skin

1. Fad--Microneedling—think of a roller with tiny short needles. 

This multiple puncturing is supposed to stimulate collagen in the skin, which is the main support protein in the skin, and it purports to firm the facial skin. Some dermatologists say it is as effective as microdermabrasion, which stimulates collagen as well. It is available online….roll on!

  I can’t imagine how many treatments it takes to see reasonable lasting results. The number of skin treatments available by salons is staggering, and most are of little value unless sun protection, not smoking, little alcohol, and a healthy diet and great hydration are added t good sensible skincare. Temporarily microneedling could swell the skin slightly, create minimal collagen deposition, and cause some smoothing of the skin. Be careful of bacterial skin infections especially at salons. Talk to a dermatologist.

2. Failure--Collagen creams for the face cannot penetrate the skin and deposit collagen. Hemorrhoid creams for puffy eyes do work some because of the vasoconstrictive ingredients, but should not be used every day because many contain hydrocortisone and will thin the skin.

  Placenta (stem cells) creams and facials, and stem cells in fillers have shown no value above and beyond regular facials and good quality creams. Topical water sprays will not improve the appearance of the skin unless a person’s skin is dehydrated, but drinking 8 glasses of water a day is still vital for healthy skin and organs. 

Threading of sutures used to be popular but too many became visible. but the material can accomplish filling of wrinkles in expert hands. Injectible fillers are a lot easier and much more effective, but need repeating every few months.

3. Fixes—Cone sutures are now popular and under local anesthesia are run under the skin and these collagen sutures dissolve after 2 years. They do stimulate some collagen and provide some conservative cosmetic effects.

 As one can see below, the results are very conservative.

Cosmetic facial fillers (Restylane, Juvederm, Perlane, Radiesse) contain collagen and hyaluronic acid which can plump and fill wrinkles for several months, but need repeating. Lips and smile lines can be improved

I will report on all these procedures in the future in a cosmetic series. Most cosmetic moisturizing creams that contain humectants which draw water to the surface of the skin and help smooth skin over time, but internal hydration is a must.

Laser resurfacing and removal of dark spots on the face are very effective, but bleaching agents and extreme sun protection (UVA and UVB blocks) are necessary or the spots will return (I performed hundreds of these procedures with good results, but loss of pigment is a potential side effect. These are only for mildly pigmented skin people.

3. Medical Updates

    A. Measles Outbreaks continue—the costs to the taxpayer

Red measles (as opposed to German measles-Rubella) outbreaks continue throughout the country thanks to anti-vaccination advocates in certain groups that refuse to vaccinate their children. Coughing and sneezing easily can transmit the virus.  Although several hundred children have been infected, those who have been brainwashed and refuse to protect their children even though they are not allowed to go to school. They selfishly expose others to the virus out in their communities.

  As of July, 2019, the CDC announced that there were over 1019 active cases of measles in 15 states with 6 states (including Georgia) with outbreaks. The CDC advises anyone traveling internationally be vaccinated with the MMR vaccine (Mumps, Measles, Rubella).

  The high numbers (41,000 in 2018) of measles cases in Europe affects our numbers as people are exposed by immigrants or those to travel to France, England, Germany, Italy, and Greece.

  Religious exemptions are being removed in New York, Maine, Arizona, California, Mississippi, and West Virginia. Other states will likely follow.

  An Amish community in Ohio has a breakout, a Somali community in Minnesota had 75 cases in 2017. There was a large measles outbreak at Disneyland in California in 2014-15. The New York City suburb (Rockland County) had 155 cases and declared a statewide emergency outbreak came from Orthodox Jewish communities primarily from Israeli visitors.

  Anyone under 18 is not allowed to be in public places if unvaccinated for measles or Rubella for 30 days or until they are vaccinated. In Queens and the Bronz have 214 confirmed cases.

  In 2000, the U.S. had eliminated outbreaks. These are mostly people who have religious or philosophical exemptions that have created these outbreaks including Oregon and Washington.

  A study was reported in JAMA about the healthcare costs of these outbreaks. The public health cost of responding to a single case can be as high ad $142,000 due to U.S. requirements. For mobilization of the U.S. Public Health Department employees, salaries, overtime, doctor costs, medications, cost of medical care from complications of measles, quarantines, post-exposure use of immunoglobulins, etc., the CDC announced the total cost in 2011 cost $5.3 million.

  The Congress needs to reexamine the exemptions allowed and toughen up the requirements for vaccination. Also these are just numbers reported….probably many hundreds more go unreported.

  I am currently working on a story about the impact of all the diseases illegal immigrants are bringing to our country.  THE TAXPAYER IS PAYING THESE COSTS.

  Special groups that live in our country do not intend to assimilate tour U.S. standards of living will continue to be a burden to our country.

  With hundreds of thousands of illegals coming in through our borders will just worsen these types of communicable disease issues. I am reporting on the entire issue of diseases coming through our borders in October.

  Immigration reform must be passed, and both our political parties must quit playing politics with this border immigration national crisis.

   JAMA, March 25, 2019

B. Can mammograms be comfortable and still diagnose cancer as efficiently?

Mammograms

  Mammograms can be very uncomfortable because the breast tissue must be compressed considerably to get an accurate reading. However, it is uncomfortable and often can be a deterrent to getting repeated mammograms.

  A study in a Scandanavian country performed a study on over 500 women who were personally allowed to put the amount of pressure on their breasts for a mammogram instead of a technician. The women were carefully instructed and overseen by the technician. The percentage of cancers and abnormalities was statistically the same for this group compared to an equal number of women who had the technician adjust the pressure on the breast in the machine.

  Interestingly, the women put about the same pressure on their breast as the technician, and claimed the procedure was less painful.

  Although it took a little more time, allowing women to have more control on the compression of their breast for a mammogram should be considered. The end result could encourage more women to have screening mammograms. NEJM, Women’s Health, 2019

C. Textured breast implants recalled for cancer risk

The pharmaceutical company, Allergen, marketed textured breast implants (Biocell textured surface) and tissue expanders and at the request of the FDA has recalled them worldwide because of the rare occurrence of a rare type cancer. The specific type of implant is a macro-textured implant, and most of the cases have occurred from this specific type of breast implant or tissue expander.

  The FDA will continue to closely study these cases and could expand their recommendations to other types of implants in the future.

  As of July,2019, there have been 573 reported cases of implant related cancers (376 cases in the USA), and 85% of the cases have been linked to Allergan’s textured breast implants. 99% of actual breast cancers are adenocarcinoma and not this type of cancer.

  There have been 85 worldwide deaths reported (48 in the USA), but if treated early is curable. These numbers may well be incomplete and therefore inaccurate, since some may have never been reported. Many countries have already banned the use of these textured implants and tissue expanders.

  There is a 6X greater chance of developing this rare cancer around a textured implant as opposed to a smooth surface implant.

  The cancer is called anaplastic large cell lymphoma. It is theorized that the textured surface of a silicone or saline implant may cause more of an inflammatory response which might lead to this rare cancer. This implant surface does not cause breast cancer. There have been only 26 cases in smooth implants, but women should always be vigilant in having their mammograms and be aware of any changes in their breasts.

  50% of these patients developed the rare cancer within 7-8 years after implantation. In most of these cancer cases, there has been success by surgically removing the implant and surrounding scar tissue.

  The FDA is NOT RECOMMENDING the implants be removed without symptoms because of the extreme rarity of this cancer. The FDA reports that there is a risk of only 1/100,000 breast implants of developing this cancer with over an estimated 10-15 million having been implanted to date worldwide. There are specific guidelines for surgeons.

  The FDA strongly recommends careful surveillance of these women and education about the possible signs that might be cancer—swelling around the breast implant with fluid accumulation, hardness, or a mass. If these symptoms occur, imaging and other exams are recommended (MRI). If this cancer is diagnosed, an experienced clinician dealing with this type of cancer, should be consulted.

  If the textured implants have given the women no signs described above, please consult the surgeon who placed them about observation versus consideration for removal. The risk is extremely small, but worry is inevitable for women who have had textured implants.

  Many women may not know if they have had textured implants and should find out. Theoretically Allergan and or the surgeon should be contacting all women who have had this type of implant, but don’t wait if you know you have  textured breast implants for peace of mind.

  I discussed these implants and this side effects in a previous report in July, 2018—click on:

www.themedicalnewsreport.com #78

  FDA Report, July 23, 2019  

D. Gluten is present in 30% of restaurant food that is labeled gluten-free

  USA Today announced recently that researchers  have reported in the American Journal of Gastroenterology that 30% of restaurant food that is labeled gluten free in fact contains gluten. Gluten is the protein that is injurious to the small bowel of patients with Celiac disease.

  Although a wide variety of foods were found to contain gluten, pizza and pasta were the highest offenders, even though these foods were labeled gluten free.

E. Healthcare costs and our fractured Congress; Big Pharma winning!

  1- We all want healthcare costs reduced, but since the cost is 18% of GDP and so complex, there is no easy answer to getting medical costs under control including the single payer proposal. I doubt it is going to happen.

  Even with the high cost, a recent article in the NEJM (June, 2019), 69% of the public thinks the U.S. Government should be taking a bigger share of the cost of healthcare, which encourages a single payer proposal.

  The complaint comes from most feeling that the healthcare services are too costly and affects their bottom line. 78% point to medication costs, 71% on the cost of hospitals, and 75% on the cost of insurance. 76% feel they are paying too much for the quality of the services they receive. In other words, people want someone else to pay, and whether it comes out of our taxes or we pay for direct services, the cost will still affect everyone in one way or the other.

Statistics for the following healthcare issues:

a) 84% want better preventive services and ensure that people live healthier lives.

b) 67% want the government to facilitate more competitive pricing for healthcare professionals and hospitals and better quality.

c) 65% want the government to limit what doctors and hospitals can charge.

d) 61% want people ages 50-64 to have access to Medicare.

e) 50% want the government to allow everyone to have Medicare.

f) Most do not want any restrictions to treatments and medications. Wow! Such lack of understanding about healthcare and its cost.

  The above statistics came from the Department of Public Health at Harvard University. What these statistics do show, is that healthcare is one of the most important political issues alongside of economic prosperity and will make the presidential race for 2020 very close. Of course, as most of these articles exclude, is how the public pays for this…..increased taxes which means only half of Americans will pay for the other half. It is estimated that single payer insurance will cost $15-30 trillion over 10 years.

  Why the increasingly progressive public trusts the government is curious, since the Congress’ rating is less than 10%. Why would they trust these jokers to do a great job of running healthcare? It certainly will make the presidential debates worth watching.

Hidden costs from out of network services

  A common hidden cost comes from surprise bills when having services from a specific healthcare network, for example, the emergency department. Not infrequently someone or some service is out of network, and patients get a large bill which patients assumed were covered under the network.  A bipartisan congressional bill stopping such surprise billing is sure to pass. These services will be required to provide the cost up front for non-emergency care.

  President Trump worked hard to get pharmaceutical rebates given to the patients instead of them going to the insurance companies and pharmaceutical supply managers. The Congressional Business Office convinced President Trump to back off, because it was felt that it would automatically raise drug prices. Another loss!

Big Pharma continues to win

   Big  Pharma continues to win in Washington thanks to the lobbyists. They won the fight that Trump proposed to make TV ads provide the monthly price in the TV ad. They prevented rebates on drugs from going to patients.

  They have been able to influence Congress to water down regulations and prevent what President Trump has been fighting for since taking office (negotiating with Big Pharma). He has proposed that the U.S. pay no more than the prices of other countries for Medicare patients and has bipartisan support, but with no cooperation in Congress, nothing will happen before the elections.

  They have influenced Congressmen to water down new patient regulations with over $200,000 campaign contributions in the 2018 election cycle (58% to Repubs and 42% to Dems). Can you imagine what this presidential election will bring in contributions from the lobbyists of Big Pharma?

  The fractured Congress (and in-fighting in the Democratic pary) will continue to provide little being done before the  November 2020 election. Even the Republicans are waiting to come out with their proposed healthcare plan until after the election. It is obvious why they are waiting! They need the lobbyists’ money. Clearly the lobbyists have a tight grip on our elected officials (both parties), and they need to be stopped! Big Pharma lobbyists influence them donating large sums of money for their re-election campaigns. Why is that legal???? The answer is that the Congress would have to change it…..  

  Big Pharma has replaced Big Tobacco as the most powerful broker of deals in Washington, according to Democratic Senator Dick Durbin of Illinois. Our political parties will never get together with the current environment, so there will be a lot of talk and promises from candidates but in the end, I doubt much will be accomplished when it comes to healthcare before the presidential elections.

  2-- Effect of U.S. Trade Agreement and Big Pharma

  The U.S. Free Trade Agreement has great influence on the pharmaceutical industry. This industry has prospered greatly with our agreements, but when the taxes went up in the U.S., industries moved many of their pharmaceutical plants out of the country, like the auto industry and others did. Ireland which has only a 12.5% corporate tax rate, and is now the leading exporter of pharmaceuticals.

  The FDA estimates that 80% of the active ingredients  and 40% of the finished drugs are imported to the U.S. which drives the prices higher. The drug trade deficit has ballooned to $52 billion. The number of pharmaceutical employees (297,300) has not substantially changed since 2001, which tells you they are not helping American employment.

  NAFTA was very positive for Big Pharma. However, since President Trump dropped NAFTA, things have changed. Drug prices outside the U.S. have enjoyed lower prices, but  hopefully that will change and we will see lower prices at home. Drug prices are out of control for now. But there are some positives such as biosimilar drugs, which dropped the price of those drugs by 50%.

  However, with the creation of the agreement between Canada and Mexico (USMCA),  the most expensive biologic drugs have patent protection for 10 years, and immediately Big Pharma raised biologics (Humira, Enbrel, interferons, etc.) by 25%.

  Keeping U.S. companies here in our country has good and bad consequences, and it was President Obama who initially gave the biologics a 12 year window of patent protection. 

  Biologic drugs account for only 1% of the drug market but 30% of the cost of drugs today.  Generic drugs account for 90% of the drug market, but only account for less than 10% of the drug costs. Without biologics, prices would be down. Have you seen a TV commercial that was something other than a biologic drug? And now the drug company does not have to tell the public the price on TV, thanks to a court decision.

   Laws passed by our Congress have protected Big Pharma long enough. Know that laws on the books can’t just be changed over night, so don’t expect either political party to change the overall picture anytime soon if at all.

  Drug costs have risen from $236 billion to $333 billion per year between 2007 and 2017.

  Keeping more industries like the drug industry in our country could lower costs and also make our Congress have a better chance of negotiating with Big Pharma.

  The value of the change of the trade agreement with China alone will have major economic advantage for the U.S. even if certain companies are negatively affected for the short term. Short term pain can bring long term gain.

Reference—NEJM, May 1, 2019

4. Medicare for all---A look at proposed healthcare plan—my opinion!!

  Medicare cost $710 billion in 2017. A year ago illegal immigrants cost Americans $74 billion for approximately 10 million illegals immigrants. California wants to give them Medi-Cal, and the Democrats want single payer healthcare (except former VP Biden) and free healthcare for illegals. In 2011, the cost of medically paying for the uninsured and underinsured was $41.1 billion in 2006 (that was 13 years ago). Single payer is estimated to cost $30+ trillion over 10 years. If you add 29 million uninsured and probably 15-20 million illegals by the time it could be initiated…..well you get the idea!

  Medicare for all (and insurance for illegals) is primarily driven by millennials (age 18-34), the media, and the far left Democrats including most of those in the primary trying to get the Democratic nomination. It is a shame that the traditionally moderate Democrats have been forced to be a much more progressive party. I wonder how many really support single payer once the primaries are over.

  It is a shame that the media, groups like the “Squad” and younger people are pushing us toward socialism. It won’t work if we want to keep the America we grew up in.

   It all began with Senator Bernie Sanders’ premise that healthcare is a basic right for all Americans, which creates a separation of ideology right from the beginning. Where in the U.S. Constitution does it say that healthcare is a right? It is the beginning of the socialistic mantra first proposed by Bernie and now Senator Elizabeth Warren followed by the “Squad” and their followers including almost all the Democratic candidates.

  For many, healthcare is a privilege that should be paid for. Most middle aged and seniors paid into Medicare their whole professional lives, and we don’t consider Medicare an entitlement!

  Everyone is entitled to buy insurance for sure, but even poor people need to pay something. There should be no free rides. “Free stuff” just is not appreciated and often abused. Entitlements begin dependency on government. That is one of the basic socialistic aspects for developing a socialistic society. By the way, we have a $21 trillion national debt right now.

  This ideology separates the country, but it is the major premise upon which providing healthcare for every individual in this country lies. Even those who are “ok” with this concept still want to know how are we going to pay for it!!!! TAXES!

  Where is the money for all those who are mentally ill, need treatment for drug addiction, the homeless and needy American citizens? And where are the funds to protect the borders and help those who are legally coming to our borders legitimately seeking asylum? 

  Healthcare costs are out of control for many reasons and no one has any easy answers to resolve the high cost. The fact is, Americans are spoiled and are used to top quality services even though they complain about the price. Are we really willing to give it up for the sake of covering all people in this country with some mediocre form of socialized healthcare?

  In a free enterprise, capitalistic society with certain governmental rules, there are limitations as to how healthcare reform can occur. Big Pharma, private insurance companies, health care providers, large medical centers, and other factions of medical care have rights too.

  In other words, no matter what kind of healthcare coverage we have, there are winners and losers. With socialized medicine, winners are the poor, the uninsured, the illegals, and the government since they would be more powerful than ever and dictate the kind of care we get. How will a fractured Congress ever make the rules?  

  No state as yet has been able to accomplish this type of socialized healthcare (remember Romney care in Mass. and the Vermont system). No country has made socialized medicine successful unless you are willing to accept less access, less services, longer wait times, rationing of care, refusal of elective surgeries especially for the elderly, and fewer hospitals especially in the rural areas.  

  Even starting Medicare at 55 will bankrupt the system. Medicare will be insolvent in the next decade as it is!  

  Rural hospitals already are closing, as they are stuck with primarily only Medicaid and poor patients. 83 rural hospitals closed since 2010 and 673 are vulnerable for closure according to a Medscape article citing Vantage Health Analytics. This is especially true in the South and nearby states.

  There were 6210 hospital in the U.S. registered in 2018 according to the American Hospital Association. With an estimated reduction of 20-30% of current hospitals over the next 10 years, single payer insurance will break our system. 

  Adding all the illegals flooding our borders (and it will get worse), we will be overrun with the poor of the world.   

  No industry that monopolizes any form of business has not created higher prices, and it will force doctors who provide office services at a lower cost to bow to the big medical care facilities, which charge 20-30% more on the average 

  When there is no deductible or copay by patients (so says Bernie), it has already been proven that there is overutilization of services and abuse of the system. It totally takes any responsibility for a patient to assist in their own healthcare. The doctor-patient relationship requires cooperation between doctor and patient. As a physician, I have seen what happens to patients who do not take responsibility for assisting the doctor in their care….poorer healthcare outcomes…the very way quality of care is now measured.

  Ever heard the question…..if you don’t like the cost of healthcare today, wait til its free!!

 Here is a look at some of the things that we will give up:

1. Employer based healthcare plans will be lost and choice of doctor and hospital will be lost for the 170 million people getting their insurance from their employer.

2. Current plans will be lost, and everyone will have the same plan.

3. Choice of doctor and hospital will likely be lost.

4. Doctors will be paid approximately 40% less. Doctors will retire even earlier, be forced to see more patients per hour, and quality will suffer. Primary care medicine will be run by nurse practitioners and PAs.

5. Hospitals only receive about 85% of the their costs from Medicare currently, and the private insurance companies pay usually 110-120% to hospitals to make up the difference. With at least 15% loss of income, hospitals will have to cut back on services to their patients. Will the feds foot the bill? Rationing, long waits for services, and much fewer new innovations will occur. Just look at other countries.

6. Medical research and teaching of doctors in medical centers are supported by the private insurance payments to hospitals. Who will train our doctors? Even if medical school is free, who will pay for it? YOU!

7. Patients will have to pay higher prices for services not covered, and that will create a second tier of coverage which cost patients even more if they can afford it. That cost will be topped with increased taxes that will need to occur to cover the $30 trillion cost over the next 10 years for single payer socialism.

8. Single payer plans in other countries do not work, and have created a tremendous burden on their citizens.  Some countries allowed a second tier plan for those who can afford it to continue their current services.

9. Most of us paid into our paychecks a Medicare payment throughout our working lives to pay for Medicare, and that money is going to run out in the next decade, including social security. Those who have paid into these plans do not want to give it to those who did not pay their share. California is already planning to give free healthcare to illegal immigrants and so are most of the Democratic candidates. Nothing is free!! Someone will pay….YOU!

10. Capitalism is at stake!!; free enterprise too! Innovation gone! Those who support socialism are ill-informed.

11. Young people who support this ideology are still on their parent’s healthcare plan til 26. These folks have not had time to progress in their careers and realize what they make in salary deserves to stay with them. Everyone must pay their way for our country to thrive. Not just those that pay taxes.

12. College kids are being brain washed by liberal professors (90% of professors are extremely liberal) that socialism is the way for the future. They do not hear conservative values and discriminate against them when they try to provide information to these college students.

  The academic American Medical Association and other national doctor and hospital associations may support single payer, but the majority of the doctors and hospitals doing all the work are totally against Medicare for all, because they know it won’t work.

  As much as I felt Obamacare was a disaster, we must get our politicians together and fix healthcare for the uninsured and underinsured and leave the rest alone for now. Why interfere with the rest of healthcare when over 85% of Medicare recipients are happy with what they have. Trying to change the whole system is foolhearty and not affordable ($30 trillion over 10 years).

    I remind you that most of the comments are my own, however, the statistics are from national statistics organizations and articles in JAMA.

  JAMA, June, 2019, their viewpoint from an academic School of Urban Public Health

5. Migraine headaches—updated information

I have discussed migraine headaches in detail.  However, the information needs to be updated with so many advances in the past couple of years. For the basics including the classification of migraine, click on:

www.themedicalnewsreport.com #26 , #28 and #29

Review

  Migraine headaches affects 20% of women and 6-10% of men, and is one the top ten illnesses that humans endure (approximately 37 million Americans). The highest incidence occurs in 18-44 year olds. One third will have a warning that the migraine is about to occur (called an aura which can be a visual cue or a sensation such as numbness, etc.).

  Approximately 14% of migraine sufferers experience 5 or more migraines per month. 25% report missing work or other activities. Many have been misdiagnosed. These patients suffer a relatively sudden onset of head pain (throbbing and pulsating) with or without sensations prior to headache or not and almost always are one-sided (unilateral). They are brought on by stress, changes in hormone levels in women, hunger, too little (or too much) sleep, lack of regular exercise, dietary elements (red wine, caffeine, MSG, artificial sweeteners, nitrates, and even odors (perfumes, cigarette smoke, etc.).

  The headache progresses over 1-2 hours and usually proceeds from the side of the head to the back of the head and upper neck (tension component) that can last as long as 72 hours. They can progress to involve both sides with prolonged duration.  Nausea occurs in 80% with vomiting in 50%, loss of appetite, and sensitivity to light and sound.

  Many precipitators can bring on a migraine: hormone changes during menstrual period and birth control pills, pregnancy, and ovulation. Also excessive or insufficient sleep, stress, smoking, exposure to bright or fluorescent lighting, strong odors (perfumes, petroleum products, etc.), head trauma, weather changes, motion sickness, cold stimuli, lack of exercise, and red wine (tannins, nitrites) can bring on a migraine. 

Tension-vascular headaches

  Having seen hundreds of patients in my practice with headache, there is a subset of patients that have severe tension headaches with a vascular component that respond to muscle relaxants/tranquilizers (Valium), and migraine medication. The reverse is true…migraines have a tension type headache component as well. These two types of headache are often confused even by some doctors. NSAIDs (ibuprofen and Aleve) in combination with migraine medications may help both groups.

Treatment of Migraines

  Tryptans are serotonin agonists, which means this class of drugs stimulate receptor sites in the brain that secrete serotonin, a neurochemical transmitter in the brain (and gut) that are involved with sleep, mood, behavior, appetite, digestion, memory, sexual desire and function. They also vasoconstrict blood vessels, which is one of the key aspects of migraine (dilation of vessels causing headaches) and make nerves less excitable. Migraines are one of the top 5 reasons for emergency department visits.

  It is now known that symptoms may persist long after the headache with continued pain (varies widely) creating disability and inability to normally function and work. There is a great concern for opioid abuse.

  Here is the latest information on migraines from several articles in medical journals.

Medications--acute and preventative for migraine

  1—Acute Migraine Therapy

  NSAIDs are commonly often used by these patients (aspirin, ibuprofen, naproxen, etc.), caffeine, and  acetaminophen (Tylenol). When presenting to the emergency department, any number of medications may be used including the trptans-sumitriptan (Imitrex), ergotamines, ketorolac, anti-nausea meds, corticosteroids, and opioids.  Transdermal treatment on the site of the headache with topical powder sumatriptan (iontophoresis) may be effective. These medications directly or indirectly constrict the vessels in the brain and dura (lining of the brain) that dilate with migraine.

  Triptans are the most often prescribed. There are 7 different tryptans, and some may work better than others for each individual. Imitrex is often used because it has several delivery methods (intranasal, subcutaneous injection, and oral formulations) with an 82% effectiveness rate at 20 minutes by injection.

  Other triptans very effective are Zomig, Maxalt, and Amerge and Frova. The 2 latter drugs help in prolonged migraines. If one of these does not work, tell your doctor, and they may switch to a different one.

  An FDA approved combination pill containing naproxen and sumatriptan (Treximet) is of significant value. An injection or suppository of Phenergen will sedate and relieve nausea in addition to the migraine medications for more severe migraines.

  Once a migraine occurs, patients are usually in need of immediate treatment. There are many combinations of medications that might include a combination rectal suppository of caffeine, phenobarbital and ergotamine (Cafergot), because by then, the patients are nauseated and or vomiting, with photophobia (light sensitivity), and are enduring a pulsating temporal unilateral (one-sided) headache looking for a dark room. Suppositories and injections prevent having to take something oral when the patient is nauseated and vomiting.

  Patients need to have these medications available to them at home so that at the first sign of a headache (aura or not), they are taken, as medications are much more likely to be effective if taken in the first 15 minutes.  

  2—Migraine Prevention Medications—selection of patients for preventative medication usually include those with 4 or more headache episodes per month. The goal of this treatment is reduce the number of episodes by 50%. There is often a delay in improvement, therefore, it may take 2-3 months.

   a) Methylsergide (Sansert) was the first medication to prevent migraines and in the studies 57% of trial participants patients experienced at least a 50% or greater reduction, but side effects have made this medication no longer the first line treatment protocol.

    b) Ergotamines also fell out of favor (long term use caused fibrosis in the lungs and back of the abdomen) in the 1980s when the tryptans were first introduced. However, some studies report that naproxen 500mg is as effective as sumatriptan 100mg. The use of opioids in the emergency departments should be reserved for those not responding to more conservative measures, as the chance of abuse is high in these patients.    

    c) Antidepressants-tricyclics (amytryptiline, venlafaxine),

    d) Anti-seizure medication topiramate (Topamax), sodium valproate(Depacote),

    e) Antihypertensives- beta blockers (propanolol, metoprolol), calcium channel blockers (Cardiazem, Cartia, and Tiazaca).

    f) Botox (injected between eyebrows, temple, and scalp) has become a significant preventative for migraines which is injected every 2-3 months. The nerves between the eyebrows actually connect with nerves that innervate intracranial blood vessels that dilate when a migraine occurs. It can reduce the number of migraines by 50% in patients compared to Topamax (12%) as reported by the American Headache Society.

When I performed cosmetic forehead lifts, I cut these nerves between the eyebrows when cutting the frown muscles and patients often told me I got rid of their migraines not to mention their forehead wrinkles. When Botox injections became popular to paralyze the frown muscles, patients noticed their headaches were relieved as well. Only 4% stopped Botox (usually every 3-4 months) compared to the above named drug (50% stopped because of side effects of the drug).

    g) New Class of Preventative Medications-monoclonal antibodies

  3 different drug companies introduced these meds- fremanzumab (Ajovy) and erenumab (Aimovig), and  galcanezumab (Emgality) were recently FDA approved to prevent migraines. These are monoclonal antibodies made from human cells and are used also in cancer treatments targeting specific antigens in cancer cells. These are not usually recommended unless the above medications fail because fo the side effects (flu like syndromes with rash).

  The monoclonal antibodies affect the calcitonin gene-related peptide (CGRP) pathways for pain modulation. This peptide increases during a migraine. This is a 37 chain amino acid peptide and functions as a neurotransmitter in the nervous system and is a vasodilator. Reversing blood vessel dilation on the surface of the brain using these monoclonal antibodies is the key to stopping a migraine since the dilation stretches the nerves surrounding the vessel causing the pain of migraine.

   h) Tapering preventative medications

  If these medical treatments are effective, attempting to taper off these medications after 6 months might be considered according to the Institute of Clinical Review article to reduce side effects. Adequate treatment is challenging because patients stop their meds due to intolerability from side effects (flu like symptoms, rash, nausea, vomiting, etc.). It makes Botox a very good choice. Check with your doctor about these options, since these medical treatments come with systemic side effects.

Devices--Nerve stimulators

  I have discussed the use of a FDA approved device called Cefaly in a previous report that is a headband that is connected to a machine that gives out electrical impulses that stimulate those nerve between the eyebrows connected to migraines and is used for 20 minutes once a day. It also could be a sham procedure, but I have seen no studies comparing it to a placebo treatment.

The Cerena Transcranial Magnetic Stimulator may be effective in migraines with an aura in patients older than 18, not helped by standard therapy. The magnetic stimulator is placed on the back of the head and pressing a button to release a magnetic pulse that stimulates the occipital cortex (one treatment per 24 hours). Those with implants or metal in their head should avoid this stimulator. I found no study regarding its effectiveness. Another nerve stimulator to the neck (vagus nerve) named nVS is FDA approved, perhaps effective in 10%.

Relaxation techniques—Biofeedback, meditation, behavioral therapy, and any form of relaxation to relieve stress may be helpful.

Complementary therapy

   The herb butterbur (with anti-inflammatory effects) may prevent migraines, however, liver tests must be monitored if it conrains PA-pyrrolizidine (look for a certified PA free product). Vitamin B2-riboflavin, magnesium, and feverfew, Co-Q-10, melatonin, yoga, massage, chiropractic manipulation, acupressure or acupuncture, and biofeedback may all be helpful.

  Cannabis use is very commonly used by migraine sufferers according to an article in the Journal of Headache and Pain. In a questionnaire sent to 2032 migraine sufferers, over half used highly concentrated THC (tetrahydrocannabinol), the psychoactive ingredient in marijuana. Half used cannabis as a substitute for a variety of pain meds. This study only points out how common patients with chronic pain syndromes use cannabis, whether legal or not. This was not a controlled study, but may be much less dangerous than opioid addiction.

  If a person is having good results with cannabis products, they should tell their doctor, as they need feedback on its benefits. Doctors need to get up to speed on its benefits and limitations.   

Treatment of persistant migraine (Status Migrainosus)

  Approximately 40% of migraine attacks do not respond to triptans combined with other medications or not. If the migraine lasts 72 hours, patients should be treated in the emergency or urgent care departments including admission. Treating with IV valproate (Depacote, Depakine) or dihydroergotamine (Migranal) for a few days in the hospital may be necessary.

Perimenstrual migraine

  If these patients are not responding to prevention methods, oral estradiol 0.5mg orally twice a day or a 1 mg patch may prevent menstruation where drops in estrogen occur.

Chronic migraine

  There is a smaller number (10%) that are diagnosed with chronic migraine, characterized by 15 or more headache days per month for at least 3 months.

Surgical treatment

  Cutting the nerves between the eyebrows (as is done in a cosmetic forehead lift) can be performed with about 50% results. Some nerves can grow back over time.

Foods and Drink that might trigger migraines

  There is controversy when it comes to diet and migraines. However, most patients report certain foods and drink can trigger migraine attacks. The most common reported are alcohol especially red wine and beer, caffeine overuse, chocolate, aspartame (Nutrasweet, Equal, etc.), MSG, certain fruits (banana, citrus, avocado, dried fruit), and tyramine, an amino acid that accumulates with aging but is also found in aged cheese, bacon, sausage, lunch meats, cured and smoked meats, pickled foods, heavily yeasted bread, wine vinegar, and certain beans.

Guidelines for treatment

  The American Headache Society has released guidelines for treatment of acute migraines. Consult their website for more information, but they align with what has been reported here.

 www.emedicine.medscape.com

JAMA, 2018, WebMD

6. Impulse Control Disorder Syndrome

  There is a new classification for impulse disorders and has been separated from obsessive-compulsive disorders. This is involves 1-5% of the U.S. population.

  These impulse disorders are defined as a class of disorders that have impulsivity, meaning failure to resist a temptation, an urge, or impulse, or inability to not speak on a thought.

  Many psychiatric disorders include impulsivity including substance abuse, ADHD, anti-social and borderline personalities, behavioral addictions such as sex addiction (5-6%), compulsive buying (2-8%), gambling, internet addiction (no stats yet but is problem is huge), and conduct disorders such as kleptomania (6 in 1000). 5% of shoplifting comes from people with this syndrome accounting for 100,000 arrests per year in the U.S.

  There are 4 characteristics of impulsivity—1) an impulse with increasing tension, 2) getting pleasure while acting on the impulse, 3) relief of urge from the act, 4) followed by guilt (but not always).

  This disorder also includes internet addiction and intermittent explosive behavior (road rage, frustration, etc.), and pyromania (2.5-3.5%) usually in young males.

Co-morbidities (co-existing disorders)

  Late Parkinson’s disease is known to have this disorder. 12-20% have genetic tendencies from parents. ADHD is another example.

Treatment

  For any psychiatric disorder, there are a variety of medical and psychosocial therapies. These medications tend to be in the anti-depressant category.

  Specific drugs include fluvoxamine, clomipramine, fluoxetine, paroxetine, and the SSRIs (serotonin meds). Therapists must analyze the situation and make a determination about combination therapy, which is almost always more effective. Support groups (AA, Gambler’s Anonymous, etc.) also may assist in many patient.

  Cognitive therapy is the most common type of therapy, but others include aversive, covert sensitization, stimulus control, and coping skills. Relapse is a huge problem and must always be addressed….one day at a time. Wikipedia   

This completes the August report:

September report will include:

1) Psychosis

2) Cancer survivorship series--#6—side effects of chemo/radiation

3) Human (sex) trafficking

4) Medical Updates—No low dose aspirin for people without heart disease; HPV+ vocal cord cancer; Cough and gastric reflux; Nasal spray for depression; New drug for daytime drowsiness from obstructive sleep apnea

5) Roles of Ophthalmology, Optometry, and Opticians

Stay healthy and well, my friends, Dr. Sam