Pro Pharma Talks

___ Make sure to subscribe to get the latest episode. Contact Us: Pharmacy Benefit News: http://www.propharmaconsultants.com/pbn.html Email: info@propharmaconsultants.com Website: http://www.propharmaconsultants.com/ Facebook: https://www.facebook.com/propharmainc Twitter: https://twitter.com/ProPharma/ Instagram: https://www.instagram.com/propharmainc/ LinkedIn: https://www.linkedin.com/company/pro-pharma-pharmaceutical-consultants-inc/ Podcast: https://anchor.fm/pro-pharma-talks

___ Make sure to subscribe to get the latest episode. Contact Us: Pharmacy Benefit News: http://www.propharmaconsultants.com/pbn.html Email: info@propharmaconsultants.com Website: http://www.propharmaconsultants.com/ Facebook: https://www.facebook.com/propharmainc Twitter: https://twitter.com/ProPharma/ Instagram: https://www.instagram.com/propharmainc/ LinkedIn: https://www.linkedin.com/company/pro-pharma-pharmaceutical-consultants-inc/ Podcast: https://anchor.fm/pro-pharma-talks

____ Make sure to subscribe to get the latest episode. Contact Us: Pharmacy Benefit News: http://www.propharmaconsultants.com/pbn.html Email: info@propharmaconsultants.com Website: http://www.propharmaconsultants.com/ Facebook: https://www.facebook.com/propharmainc Twitter: https://twitter.com/ProPharma/ Instagram: https://www.instagram.com/propharmainc/ LinkedIn: https://www.linkedin.com/company/pro-pharma-pharmaceutical-consultants-inc/ Podcast: https://anchor.fm/pro-pharma-talks

1. The science of Covid-19 2. Pneumonia Vaccine 3. Immunocompromised patients do well with most vaccinations including RSV – these patients at increased risk of infections – new research indicates that vaccinations against human papillomavirus, hepatitis B, herpes zoster are not a problem to give 4. Misinformation Prevention is KEY! Once you have Covid-19, now what? – Access Precautionary responsibility Super-spreaders 5. Supporting Information ____ Make sure to subscribe to get the latest episode. Contact Us: Pharmacy Benefit News: http://www.propharmaconsultants.com/pbn.html Email: info@propharmaconsultants.com Website: http://www.propharmaconsultants.com/ Facebook: https://www.facebook.com/propharmainc Twitter: https://twitter.com/ProPharma/ Instagram: https://www.instagram.com/propharmainc/ LinkedIn: https://www.linkedin.com/company/pro-pharma-pharmaceutical-consultants-inc/ Podcast: https://anchor.fm/pro-pharma-talks

PP Talks – A Model for High Quality, Low Cost Health Care Rational -Arguments over ACA indicate that it is worthwhile to find another solution that uses basic principles to deliver high quality at low cost –The Cure That Works, by Sean Masaki Flynn Message  -- health care first rate, easily accessible, and inexpensive Singapore health care system Target – Singapore:  Elements of health care services Insurance Examples US Examples ____ Make sure to subscribe to get the latest episode. Contact Us: Pharmacy Benefit News: http://www.propharmaconsultants.com/pbn.html Email: info@propharmaconsultants.com Website: http://www.propharmaconsultants.com/ Facebook: https://www.facebook.com/propharmainc Twitter: https://twitter.com/ProPharma/ Instagram: https://www.instagram.com/propharmainc/ LinkedIn: https://www.linkedin.com/company/pro-pharma-pharmaceutical-consultants-inc/ Podcast: https://anchor.fm/pro-pharma-talks

1. Who Makes HC Policy?      a. State differences – access, price and coverage      b. Individuals affected –            i. 17M buy insurance           ii. 29M don’t have insurance           iii. MCare & Medicaid not affected – State expansion of Medicaid, but higher rates of inflation in Red States 2. Hospital Closures & Medicaid Expansion      a. ACA improving health care?           i. Hospitals closed in States rejecting Medicaid                1. States expanding Medicaid – lower and falling hospital closures                2. ACA – improved hospital financial performance w/l

What do people believe in fake medicines? 1. Differences between fake and counterfeit?      a. Counterfeit is medicine without active ingredient, contaminated, or wrong ingredient           i. Counterfeit examples – Fentanyl, Oncology meds – BCNU, Botox, Artesunate for malaria, antibiotics, meningitis vaccines, ED drugs      b. False treatments            i. Examples – fake miracle cancer cures, coronavirus treatments, nutritional supplements, cosmetic treatments, beauty treatments      c. Result – harm, loss of hope and money 2. Fake coronavirus treatments      a. Fake tests      b. Alcohol-based hand sanitizers, counterfeit respirators, biomagnetism magnetic therapy, covid-19 test packages, OMI sale therapy pipes inhalers, amniotic fluid products, colloidal silver, CBD   

PP Talks -- Is It Common for Compounds to Fail the FDA Approval Process? 1. Stages of FDA Approval Process IND a. Phase 1 – Safety – 20-100 healthy, 2 yrs. b. Phase 2 – Effectiveness – 100-500 patients, 2 yrs. c. Phase 3 – Effectiveness & ADR, 1K-5K, 3.5 yrs. 2. Vaccines a. Phase I fails = 37% b. Phase II fails = 69% c. Phase III fails = 42% d. Biologics License Application (BLA) application e. Vacc & Related Biologics Prod Adv Cmte (VRBPAC) 3. Risks a. New vaccine for new virus b. Clinical trials never succeed c. Vaccine induced enhancement d. Acquire study population ____ Make sure to subscribe to get the latest episode. Contact Us: Pharmacy Benefit News: http://www.propharmaconsultants.com/pbn.html Email: info@propharmaconsultants.com Website: http://www.propharmaconsultants.com/ Facebook: https://www.facebook.com/propharmainc Twitter: https://twitter.com/ProPharma/ Instagram: https://www.instagram.com/propharmainc/ LinkedIn: https://www.linkedin.com/company/pro-pharma-pharmaceutical-consultants-in

What is it? Colorectal cancer 3rd most diagnosed cancer in US (men & women) S/S = blood in stool, GI irritation, irregular stools, chronic diarrhea, sudden weight loss Diagnostic = colonoscopy – polyps, inflammation, ulcers, abnormal growths ACS testing guidelines Asymptomatic, negative family history, no polyps – every 10 years Low-risk polyps – 5 years High-risk polyps What causes it? Cause Age (90% of cases for people > 50 y/o) Family history Race – African Americans (new Dx 20% higher in Blacks, and death rates 40% higher) Ethnicity – Ashkenazi Jews Ulcerative colitis, Crohn’s disease Low whole grain diets Genetic predisposition Smoking, alcohol use, lack of exercise, diabetes How is it treated? Stage O, I -- Sx Stage II – Sx + Adj Chemo Stage III – Sx + Adj Chemo Stage IV – Sx + Chemo Chemo + Targeted Tx Gene types – + immunotherapy Radiation ____ Make

What aren’t people talking about health care? Rationale Covid-19 Disruptions POV and lab decreased MDs financially restrained Hospitals losing money Patients lack access New diagnoses/therapies down Telehealth rising Unemployment rising Drug cost reduction CMS force PhRMA to publish drug prices on TV Legislation disallowing gag clauses Expand pricing transparency to radio, web, print and       social media HHS maintain a public list of drugs violating rule Exempt Rx < $35/Rx Health Care Benefits Price transparency Health care = Consumer product Retailers offer basic services Robotics Convenience ____ Make sure to subscribe to get the latest episode. Contact Us: Pharmacy Benefit News: http://www.propharmaconsultants.com/pbn.html Email: info@propharmaconsultants.com Website: http://www.propharmaconsultants.com/ Facebook: https://www

1. Public discussion      - New information      - Politics      - MD subspecialties      - Sources of data      - Nonsense      - PP Disclaimer 2. Expertise      - Experts           - ID specialists / epidemiologists           - CDC           - WHO           - NIH           - Survey data           - FDA for potential treatments      - Mistakes      - Data acquisition / politics 3. Pearls      - New treatments      - Bogus treatments   

The War Over Covid-19 Expertise and the Politicization of Health Public discussion      -New information      -Politics      -MD subspecialties      -Sources of data      -Nonsense      -PP Disclaimer Expertise      -Experts           -ID specialists / epidemiologists           -CDC           -WHO           -NIH           -Survey data           -FDA for potential treatments      -Mistakes      -Data acquisition / politics Pearls      -New treatments    &n

Questions for PP Talks – Covid-19 & Children 1. Rationale?             a. Symptoms less severe than in adults             b. Children may carry the virus w/o S/S, but may transfer it             c. Data is variable and in many cases based on limited groups or on case reports 2. What do we know?             a. 22% of US population is children             b. 1.7% are reported cases (similar to China data)             c. Case breakdown =                          i. 10-17 y/o = 60%         &nbs

1. What is the current situation?      a. US – slow response, extremely poor national management, high uninsured rate, high out-of-pocket costs, and comparatively low medical system capacity       b. States in competition over purchasing PPE 2. What are other countries doing?      a. International experience – management, global partnering      b. Asian experience – using lessons learned from SARS outbreak      c. European experience – emphasize testing      d. Scandinavia           i. Swedish model – remained open, highest global death rate, economy in worst crisis since WWII           ii. Denmark/Norway – locked down           iii. Finland has low level of immunity – fears of a second wave    

1. What is off-label drug use?      a. Off-label drug use is when doctors prescribe medications for unapproved uses      b. FDA cannot control how doctors prescribe      c. 20% of Rx in US are fore off-label uses 2. Why use a drug for off-label purposes?      a. Tried all other options without success      b. Literature to support drug’s use, even if limited      c. Different dosage form      d. Dosage for which there is evidence that a higher dose may be effective      e. Drug is generic so there is no financial benefit for a manufacturer to obtain approvals 3. What are the risks?      a. Balance between effectiveness and risk is tilted toward risk      b. Investigational studies with close monitoring of safety 4. Approvals      a. Experi

1. Goal:  Lower drug cost so that they are affordable to patients      a. US Rate of Inflation (2017-2019) = 2.14% to 1.8%      b. CPI = 2.0%      c. CPI (health care) = 2.8% (2019) 2. Drug Cost Transparency      a. Transparency = cost      b. CA SB17: WAC >= $40 with 16% inflation in prior year, or 32% inflation in last 2 years 3. How do they differ?  Are they effective?  Pros/Cons      a. White House Plan      b. Congressional Action      c. Congress – Democratic Plan 4. State Plans – What are they trying to do?  Pros/Cons      a. California      b. New York  5. Discount Programs      a. GoodRx      b. TimesRx      c. Misc. 6. PhRMA unregulated for innovation &

Science & Data vs. Misinformation & the risks of overemphasizing Covid-19 to the detriment of other diseases 1. Where is the science behind Covid-19? 2. What treatments have been approved? What treatments are of no value? 3. With the emphasis on Covid-19 vaccine, what are the risks for standard vaccinations for measles, mumps, chicken pox, etc.? 4. What should we do to mitigate these risks if physician offices are not open yet? 5. People stress the need for herd immunity, but what do we do if the Covid-19 only covers =< 60% of the people? 6. Do people with immunity and/or herd immunity from common diseases (in #3 above) lose immunity without boosters or additional shots? _____ Make sure to subscribe to get the latest episode. Contact Us: Pharmacy Benefit News: http://www.propharmaconsultants.com/pbn.html Email: info@propharmaconsultants.com Website: http://www.propharmaconsultants.com/ Facebook: https://www.facebook.com/propharmainc Twitter: https://twitter.com/ProPharma/ Instagram: https://www.ins

Racism’s Impact on Health Care 1. Scope of topic = any civic, cultural, spiritual divisiveness 2. Scale = racism, sexism, antisemitism, genderism, etc., emblematic of hatred, brutality, senseless violence, exclusion, bias 3. Genesis of this podcast – police murder of George Floyd and a history of police violation of their oath 4. How do health care professionals address hatred in its many forms?      a. Merge physical and behavioral health treatment      b. Consider stress as a genesis for physical and emotional health 5. What is the position of medical, nursing, and pharmacy associations regarding hatred, violence, racism, etc.?      a. They consider it a public health care crisis      b. They conjoin the individual experience with the community experience 6. Mudd Rule 7. Inconsistencies in the health care ethic      a. Abortion      b. Access to care  &nb

1. What has changed?     a. Decreased MD office visits     b. Decreased well visits     c. Decreased oversight of chronic diseases     d. Telehealth     e. Changes in billing rules to allow for indirect patient care 2. How has technology impacted health care?     a. Historical – health care behind other industries     b. Current – catching up with telehealth, apps, home monitoring 3. What is the impact on children and people with disabilities?     a. Did not participate in financial bail-outs     b. Vaccination rates down about 40%     c. Fear of epidemics, e.g., measles 4. What is the impact on MD and DDS offices?     a. Decreased revenue, increased expenses     b. Expect to be barraged with higher severity patients     c. DDS patients delayed discretio

1. What does “second wave” mean? 2. What is transmissibility and severity of COVID-19?      a. After relaxation of interventions (social distancing, population behavior change, contact tracing)      b. Covid-19 hits during fall flu season      c. Problem is overcapacity of the health care system 3. Precedence – H1N1 pandemic in 2009 4. Immunity Passports – Chile was first to issue      a. No evidence that patients can’t get the virus again 5. What Must Be Done      a. Testing      b. Contact surveillance      c. Flu Shots 6. Treatment      a. Vaccine is first priority      b. Treatments           i. Expedited, but do not help everyone           ii. Expedite release means that safety is an i