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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

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PP Talks – A Model for High Quality, Low Cost Health Care

1. 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
2. Message  -- health care first rate, easily accessible, and inexpensive
3. Singapore health care system
4. Target – Singapore:  Elements of health care services
5. Insurance
6. Examples
7. US Examples

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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/lower probability of closure for rural markets and counties w/large amt of uninsured

               3. Supreme Court left Medicaid expansion to the States

               4. Hospital closure leads to loss of well-paying and skilled jobs

3. Wall Street – Another Option for Paying For Health Care Benefits

     a. Sell wealth management to individuals

          i. Lower cost method to gain new customers

          ii. Morgan Stanley, Goldman, Fidelity, Charles Schwab, E*Trade, Amazon/JPMorgan/Berkshire Hathaway

          iii. Wall St has the analytics to redeploy investment dollars to benefits

          iv. Same as insurance brokers?

          v. TPA/PBM – middleman model to transactional model

4. Geography Matters – John Wennberg, MD

     a. Dartmouth Atlas of Health Care – cost of living, site of care, volume of services delivered, hospital/MD salaries

     b. Example – 

          i. SF Chronicle reports cost in No. CA 30% > So. Ca d/t UC Berkeley Petris Center on Health Care Markets and Consumer Welfare

          ii. Primary reasons -- D/t consolidation in hospitals, insurance and MD practices b/w 2010-2016 (adj for higher cost of living and wages)

          iii. Result – mergers/acquisitions in health care = HP+PBMs, MD practices, Plans, Pharmacies lead to higher costs

          iv. Marketplace competition, technology, telehealth, international competition, competitor ads leverage cost differences

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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

     c. Fake treatments

          i. Hydroxychloroquine, chloroquine

          ii. Natural treatments and cures

               1. Herbal cold remedies, immune system support products, nutritional vitamins from natural sources to protect from infection, covid-19 cough syrups, natural zinc and vitamin C

3. Why do people believe?

     a. Confirmation bias

     b. Lack of credible evaluation

     c. Attention and impatience

     d. Cognitively lazy

     e. Emotions

     f. Reiteration

     g. Social pressure

4. Conclusion

     a. Skeptical of treats & cures

     b. Evidence, and confirmation

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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

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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

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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

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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

     - Comps – 2019 vs. 1918

     - Information progresses

     - Experts change opinions

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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

     -Bogus treatments

     -Comps – 2019 vs. 1918

     -Information progresses

     -Experts change opinions

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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%

                        ii. 1 y/o = 15%

                        iii. 1-4 y/o = 11%

                        iv. 5-9 y/o = 15%

                        v. 57% males

            d. Comps to adults

                        i. Peds experience less fever, cough, SOB -- 73% peds vs. 93% adults

                        ii. Hospitalization – 5.7% peds vs. 10% adults

3. Treatments?

            a. Population at risk – no widespread testing, no testing for mild S/S

            b. Perinatal transmission to neonates – guidelines require mandatory testing of neonates

            c. Infants at higher risk than older children

            d. Extrapolate treatments for adults

                        i. Prevention = hand washing, face masks, social distancing

                        ii. Behavioral changes = target stress, excessive worry, sadness, poor eating habits, unhealthy sleep habits, difficulties with attention and concentration

                        iii. Remdesivir – for hospital, severe disease – available for children through FDA Emergency Use Authorization OR through compassionate use program

4. Risks?

            a. Standard vaccinations and wellness checks

            b. PMIS-TS

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

     e. Taiwan Model

          i. Geopolitical fight with China

          ii. Serious history of respiratory diseases

          iii. Coordinate government’s response

          iv. Quick and efficient in deploying counter measures

3. What have we learned?

     a. Proactive management like every other pandemic is crucial

     b. Global partnerships are crucial

     c. Quick and efficient testing

     d. US complicated with high uninsured rate, high OOP costs, low medical system capacity

     e. US has greater disease burden

      f. US has smaller workforce and acute hospital bed capacity

     g. Considerable variation among states

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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. Experimental

     b. Benefit unknown

     c. Risks unknown

     d. Plan must pay for all consequences

5. Examples

     a. Gabapentin for anxiety

     b. High dose/strength opiates for pain

     c. Stimulants for weight loss

     d. Anti-epileptic medications for mood disorders/bipolar disease

     e. Examples of atypical antipsychotics include Seroquel, Zyprexa and Abilify. They are being used to treat an array of conditions off-label, including anxiety, attention-deficit disorder, sleep problems, behavioral problems in toddlers and dementia.

     f. Antipsychotics to treat dementia

     g. Cancer treatment – estimated 50% are off-label

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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

     a. Largest PhRMA produce 11% of leading new Rx

     b. New Rx develo9ped by universities, academic centers, NIH, hospital research groups

     c. 2/3 of new Rx developed by France, Germany, Japan, Switzerland and UK

     d. Raw materials from China, India, Israel, Brazil, South Africa, Australia

7. Transparency

     a. Shoppable vs. urgent

     b. Uwe Reinhardt – Priced Out – health care spending increases private sector > public sector

     c. Gag Order Bans (half-of-states)

     d. 8 States – PhRMA must provide reasons for reasoning for drug cost decisions

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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?

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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

     c. Cost of care

     d. Rationing

     e. Triaging based on prognosis and responsiveness to care

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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 discretionary dental work

5. What is the impact on pharmacies?

    a. Increased 90-day scripts

    b. Shortages of respiratory medications

    c. Transparency and drug cost proposals

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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 issue

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