Pro Pharma Talks

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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