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How many health studies are wrong. Editor of medpage. Ivan someting
Phase 1: test intervention in small group for safety, dosage range, side effects,
Tumor Biology retracted 100 pgs all at once. Fake peer reviews. s
PubMed commons. Any scientist can comment on any other paper. Important
source.
Pubpeer.com
Get a biostatistician. They will save you from writing about something glowingly.
They love ripping up papers.
Ivan-oransky@erols.com
@ivanorsansky
Phase 1: test intervention in small group for safety, dosage range, side effects,
How different are the outocmes? How strong are findings/ statistically signficiant?
Clinically significant wehre will change findings.
Meta analyses and systematic reviews. Systematic review. Search of existing lit. on
question using specified protocol that could be replicated.
Meta analysis. Stat. techniqes to synethesie data from several studies into single
estimate or summary effect size.
Randomized controlled trials are the point where more serious research.
Abolsute risk vs. relative risk. Relative risk reduction effect dize seems larger
Phase 1: test intervention in small group for safety, dosage range, side effects,
Abolsute is % change
What is the denominator? Actual change can be from 2 to 3 percent. Relative risk =
33 percentr reduction. Aboluste risk is only 1 % risk difference
Phase 1: test intervention in small group for safety, dosage range, side effects,
QUESTIONS TO ASK:
Phase 1: test intervention in small group for safety, dosage range, side effects,
Resources.
Healthjournalism.org/medicalstudies
Only 23% of press releases included any mention of study limitations. 22% mention
industry funding. Nearly half relied on relative risk descriptions tha are proine to
exaggeration. 23% contained more direct or explicit advice than was found in their
relvant journal articles. News stories more likely to exaggerate if press release does.
Phase 1: test intervention in small group for safety, dosage range, side effects,
Most stories dont adequately discuss cost. Then : how big are potential enefits.
Scopre of potential harmds. Quality of efience. Alternative options.
Dont use definitieve health claims made from preliminary studies and animal
research.
How did you adjust for confounding factors? I can see you adjusted for that, but how
much can you really fully account for something as complex as that? Was your
method adequate?
Phase 1: test intervention in small group for safety, dosage range, side effects,
False positives.
Then talens
Phase 1: test intervention in small group for safety, dosage range, side effects,
Personal Genetics Education Project story? Lesson plans. Johnny Kung. Our team on
website w/ email address.
Phase 1: test intervention in small group for safety, dosage range, side effects,
Rider to bill preventing embryonic stem cell research. or creating them for that
purpose.
Existing oversight:
Recombinant DNA advising committee. RAC existing body that rules on NIH funded
stuff. FDA approval.
Somatic editing research should continue and be evaluated. Germline editing should
not proceed at this stage. Though its potentially valuable.
Safety concerns:
Phase 1: test intervention in small group for safety, dosage range, side effects,
Including : only edit genes that cause disease. Continued reassessment of health
and societal risks. Broad input by public.
Phase 1: test intervention in small group for safety, dosage range, side effects,
Bright lines are appealing in rhetorical sense but misleading. No easy rules of
thumb. Nuanced decisions about complex traits.
Put what were going through now in context of history. How have we weathered
similar advances?
Phase 1: test intervention in small group for safety, dosage range, side effects,
Crispr heralded bc big step over what as there before. Turns out many different
types of crispr machinery. Is crispr the end, prob. not.
Eli Y. Adashi
Only 5 yrs ago did it become reasonably practicable to discuss germline editing
Phase 1: test intervention in small group for safety, dosage range, side effects,
2015 Jan 24, 2015 the innovative enomics intitiative forum on bioethics. Ucb and
ucsf
2015 0 nonviable and non transferable embryos worked on. Human gene editing. In
china. Protein cell journal.
NIH statement wouldnt fund any research using gene editing technologies in
human embryos. Per dickey amendment.
April 28 2015: science committee of house. Lamar smith. Doudna was on the panel
as witness. No specific conclusion drawn. But Dr. Dzau announced intiative :
intnational summit on human gene editing. Dec 2015
3 weeks after summit: Dec 2015 congress put moratorium on germline editing in US
Phase 1: test intervention in small group for safety, dosage range, side effects,
NAS Human Genome Editing: Science, Ethics and governance. Heritable genome
editing only under certain conditions.
Francis Collin suggested in 2010 that eventually we will have mandatory genome
sequencing.
Phase 1: test intervention in small group for safety, dosage range, side effects,
Deaf culture:
Deaf vs. Deaf. Upper refers to socioloingustic communites that use signed language.
Many member of the signing Deaf cultural community worry that the community is
becoming extinct.
Phase 1: test intervention in small group for safety, dosage range, side effects,
Should the deaf community be protected from this potential threat of eradication?
STORY?
Do groups have rights? Does deaf community have right to exist as a community?
Phase 1: test intervention in small group for safety, dosage range, side effects,
About 1.4 million transgender adults, we believe. And that many teens.
Phase 1: test intervention in small group for safety, dosage range, side effects,
assigned male
Phase 1: test intervention in small group for safety, dosage range, side effects,
dead name dont ask what previous name was. Name that people used before is
not their name anymore. Dont put that name into your stories. Use name they
refer. Court-ordered name changes can be hard to get.
Name and gender you get from police might not be correct
What does medically necessary mean. People crossing state lines to get
procedures.
Phase 1: test intervention in small group for safety, dosage range, side effects,
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Lymphoid arm and myeloid arm. Myeloid arm trying to under stand and evelop
therapies to target.
Phase 1: test intervention in small group for safety, dosage range, side effects,
Immune system has mechanisms against cancer natural killer cells, t cells.
Humoral immunity. Coordinated immune responses.
Immune sytem has mechanisms promoting cac er. Woundm repair inflammation.
Enhance survival pathways. Suppression of anti-tumor cellular immune responses.
Phase 1: test intervention in small group for safety, dosage range, side effects,
Mutations vary with cancer types. Number of cos. engaged in mutated neo-antigen
vaccine development.
Phase 1: test intervention in small group for safety, dosage range, side effects,
Adoptive t cell therapy with CAR t cells. Yet to make it to clinical trials.
One study 93 % went into remission for a year but a lot of relapses.
Immune checkpoint blockade. Molecule si associated with turning off the t-cells.
Block that and more t-cells. Very toxic bc not specific activates t cells for other
stuff.
Phase 1: test intervention in small group for safety, dosage range, side effects,
Antibody therapy
Checkpoint blockade/activation
In the clinical arena. Who benefits and who does not? Excpectaitons of public are
beyond what happens in clinic.
Whats next?
1891. William coley injecting cancer patients with bacteria hopiong immune
response would attack cancer.
1973 0 ID o of dendritic cells. They tell immune system what to attack and what to
ignore.
Phase 1: test intervention in small group for safety, dosage range, side effects,
Concerted effort to know who will benefit vs who wont. Hot vs. cold tumors.
Roughly 1/3 pateitne enefit. Costs 85k to 100k for a course of treatment for single
checkpoint inhibitors.
Phase 1: test intervention in small group for safety, dosage range, side effects,
Identifying those who can benefit vs those who cant is important bc of side effects
and expense.
Up to Date. Cochran Reviews. Health News REiew has guide on immune therapy.
Phase 1: test intervention in small group for safety, dosage range, side effects,
GET ABSOLUTE RATHER THAN RELATIVE RESPONSE RATES. DOUBLING RATE FROM 1
TO 2 PERCENT IS NOT SO GREAT.
SMALL phase 2 trial is much less relevant than a large phase 3 trial.
Were in a different era in which fda approved drugs have been shown to improve
large # of patients.
DCCT trial.
Phase 1: test intervention in small group for safety, dosage range, side effects,
Artificial pancreas.
Phase 1: test intervention in small group for safety, dosage range, side effects,
Quantitiative bioenergetics.
Obesity epidemic took off in 1980. Type 2. Obesity a major cause of type 2.
Eat less exercise more. 5 critical hormones that tell brain to increase or decrease
amount of food you eat and amount of calroies you born or not. When u restrict your
hormones, satiety hormones are decreased. Made in the intestines.
Phase 1: test intervention in small group for safety, dosage range, side effects,
Carolimetry. Room that meausres oxygen in and out. Can tell what calories burning
and if fat or carbohydrates. When u reduce you burn less calories become more
efficient. But hunger hormones increase so very hard.
Abdominal body fat is harmful. Fat on hips and thighs good for health.
Fat cell in stomach vs. fat cell in hips and thigh regions.
Steven.r.smith@msomething hospital.
diabetes technology
Phase 1: test intervention in small group for safety, dosage range, side effects,
last 12 years can show info about glucose in real time. Medtronic ipro 2. Continuous
glucose monitors.
Medtgronic 670G. clinical practice sue started march 2017. Was approved last
September. Insurance coverage evolving.
Phase 1: test intervention in small group for safety, dosage range, side effects,
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Phase 1: test intervention in small group for safety, dosage range, side effects,
Phase 1: test intervention in small group for safety, dosage range, side effects,
Phase 1: test intervention in small group for safety, dosage range, side effects,