Q ~ Trust Trump's Plan ~ 05/21/21 Vol.352, Q Day 1302

(h/t reformedliberal)

The following is the computer-generated transcript of a 40 minute video about corruption in medical journals, studies, pharama etc. Computer generated transcripts can lack punctuation and may have incorrect words or spellings of words.

Perspectives on the Pandemic | "The Illusion of Evidence Based Medicine" | Episode 13 Remastered - YouTube

the pharmaceutical industry

is manufacturing

all of these medical journal articles

behind the scenes

for basically marketing purposes and i

was astounded you know because i had

this enormous trust

in medical journals you have to realize

that a clinical trial on a blockbuster

drug

published in a top medical journal with

the branding

of a key opinion leader that key opinion

leaders university affiliation

is worth an enormous amount of money in

terms of

confidence what has happened

in something like the past 20 or 30

years especially with blockbuster drugs

is that we're sold a lot of

pharmaceuticals where the

risk benefit ratio is not

in favor of taking the drug and we have

all sorts of instances where people who

really didn't need to be on these drugs

took these drugs and then had serious

adverse events

so disease mongering is a marketing

scheme

of pharmaceutical companies to

persuade us to use fear

and to use our trust and science in an

extremely deceptive way

in order to persuade us to go on on

different kinds of drugs

the oligarchy of corporations here has

basically usurped cherished institutions

of democracy which involve

checks and balances in the system

but also scientific integrity

so who's looking out for scientific

integrity here's the problem

we're talking with lehman mchenry who's

the co-author of the illusion of

evidence-based medicine

so lehman if you could just tell us who

you are and a little bit about what it

is that you do

i'm a professor emeritus in philosophy

and bioethics at california state

university northridge and i'm a

consultant for a law firm called bomb

headland

eristian goldman in los angeles

california

so this book that you just mentioned

grew out of

a series of cases that i worked on as a

consultant with baum hedland

and in particular i teamed up with

a psychiatrist called john giordini in

australia

and we wrote a number of articles

together

on the subjects of corrupted

industry sponsored clinical trials

and eventually we thought that we had

enough for a book

and so the illusion of evidence-based

medicine

uh was finally produced after

uh trying to find a publisher that that

had the courage

to move forward with it and i want to

get back to what is included in that

book but

for the time being i'd like to go back

to an article

that you wrote a research piece that you

titled of

sofas and spin doctors industry

sponsored ghost writing and the crisis

of academic medicine

so first of all let me ask you what is

medical ghostwriting

how does it work and how did you

discover that it was happening

i was working on a case where lexus

smith klein

was in battle with eli lilly over

the competition to sell their top

antidepressants and one of the main

issues that came up out of this was

the problem of withdrawal or what they

call discontinuation

syndrome and one of the lawyers asked me

to have a look at

some documents that were produced in the

case

uh moving into discovery and trial and

many of them

were medical journal articles that were

published about this problem of

withdrawal particularly for paxil i came

back to him

and i said you don't have a case the the

medical literature is

firmly against you and he said

that's all ghost written don't you get

[Music]

the pharmaceutical industry is

manufacturing all of these medical

journal articles

behind the scenes for basically

marketing purposes

and i was astounded you know because i

had this enormous trust

in medical journals and i thought you

know of all the kinds of

literature that's published of

scientific literature that's published

surely

the the medical journals must be the

most rigorous and the most reliable

and it turns out the opposite is the

case and now i'm firmly of the opinion

that medical journals for the most part

should not qualify as scientific

journals

because not only because of the problem

of of ghostwriting but also

because of the problem that the peer

review system is so weak

that we really can't trust what's going

on out there in the medical literature

so describe to for us what exactly is

ghostwriting how does the process work

in my book i've identified about

four different degrees of

ghost riding but let's take the worst

case scenario

[Music]

a pharmaceutical company will conduct a

clinical trial

and they will hire a medical

communication

company to write the manuscript for the

trial

that person who actually writes the

manuscript is working for him a kind of

template he or she will be a sort of

freelance medical writer

as they are called the pharmaceutical

company

pays the medical communication company

to produce

this draft of the manuscript and then

once the draft is completed it goes to

the sponsor company namely the

pharmaceutical

company all of the marketing executives

to approve

that the manuscript is on message with

their marketing

agenda then they

will find what they call authors

[Music]

and these are what we call honorary

authors namely academics

at university hospitals and academic

research centers

who will be paid to put their names on

these papers

they might have had something to do with

a clinical trial they might have had

something to do with the design of the

trial

but they basically didn't do any of the

writing of the manuscript so

all of the marketing messages are

planted into the manuscript before

the so-called author of the paper

reviews it

and agrees that it would be published in

his or her name

and so that's the worst case scenario

here for

a medical ghostwriting and i think it's

just equivalent to fraud

because the readers of the medical

journals

are led to believe that that this

is a piece of research that is

guaranteed by the first author of the

manuscript and all of the other people

in the paper

and it very often turns out to be the

case that none of these people

have actually reviewed the data all

they've done is read the paper

and agreed to put their name on it you

came up with a phrase

the circle of evidence yes what does

that mean exactly

the the circle of evidence is my term

for

uh how if you look at a medical journal

article and you think the medical

journal article

is uh a genuine piece of science

and then that genuine piece of science

is used for

marketing purposes but it turns out that

if the paper

is ghost written it's produced by the

marketing

department in the first place so

marketing just refers us to marketing

and we go around in a circle

you quote richard horton who's the

current editor of the landsat is saying

that the medical journals quote

have evolved into information laundering

operations for the pharmaceutical

industry

so what did he mean by that if you think

of uh

money laundering is something that you

know criminals do

you've got dirty money that comes out

clean money

now in this case what you've got is

dirty manuscripts

that is to say ghost written manuscripts

that

are fraudulently misrepresenting the

science

and they're coming out clean at the

other end of the process

being produced in the medical journals

and looking like genuine respectable

pieces of scientific work

[Applause]

in the pharma materials they talk about

key opinion leaders

yes so the key opinion leader is given

lead authorship even though

they do not deserve that they're

effectively

uh signing their name to someone else's

work and

that someone else there's a go-between

of these medical communications

companies which

seem to me to basically just be kind of

medical marketing

pr firms is that exactly they're

essentially plagiarizing

uh the copy of the pharmaceutical

company

itself is that correct yeah i mean it's

plagiarism

in the sense of of you know the

so-called person who's taking authorship

credit

uh did not write this paper at all

that person might have reviewed the

manuscript and made a you know a couple

editorial

uh suggestions but but for the most part

that's about it

so plagiarism is means stealing in this

case sort of stealing credit you know

now we

look down upon this students at

university

students at university could fail a

course or be expelled from the

university for plagiarism

but it seems to be something that

flourishes

amongst professors which once this sort

of thing gets out

is very demoralizing i take it the key

opinion leaders so-called are

compensated for their work yes

p opinion leaders is a is a sort of term

of flattery

that the industry uses to lure

uh medical doctors into their marketing

agenda their speaker programs

things of this sort and they they are

compensated very handsomely

for their advice their opinion

but also they typically become the

so-called authors of these papers

now in this bizarre world of medical

communications

you have this strange distinction

between

a writer and an author which i never

have been able

to make any sense out of but uh for them

the writer is the person who drafted the

manuscript and that person's name

might be on the cover page when it's

actually produced and it's

submitted for approval to the

pharmaceutical industry

and it's only subsequently that that

page comes off

and another page comes in that includes

the so-called author

that's amazing so there's another step

that kind of almost the crucial step in

this process is the submission

to the journals so how does that work

the submission process will typically be

handled by the medical communication

company they will produce a package

which includes a cover letter

written in the so-called author's name

that will include

the manuscript for submission

and anything else that might be used for

the submission process

and there's a crucial transfer of

the intellectual property from the

pharmaceutical company

to the so-called named author of the

paper

so that now the paper becomes the

intellectual property of the honorary

author

for the purpose of submission

to the journal and for the purpose of

peer review

and all of that is is you know behind

the scenes here

we've only we only discover this in the

process of litigation

where we're doing discovery

[Music]

and the bomb headline law firm has made

a real effort

to make sure that this goes public

and that we will not settle any cases

unless we get them to agree

that these documents are made public the

journals

must be aware that this is a widespread

practice

what's their incentive for accepting

these papers

the main problem here is many of these

journals are

terribly conflicted in the sense that

they become dependent on pharmaceutical

industry money

they're dependent on pharmaceutical

industry money and in terms of the

enormous

revenue they receive in pharmaceutical

advertising

which by the way appears side by side to

these ghost written articles right so

you think okay you're getting a piece of

science here

that is to say you know the final

product of a clinical trial and then

you're getting

advertising for what might be exactly

the same

pharmaceutical but it turns out it's all

marketing marketing disguised to look

like science

now the problem here is that some of the

content of medical journal articles is

genuine

uh we can't we can't you know broadly

paint

all of the content of medical journals

as fraudulent

but the problem is the fraudulent

articles are so professionally done that

it's extremely difficult to distinguish

them from the genuine

so now what we've got is an article

that's submitted

to the medical journals and we don't

know really whether

the editors completely understand

the extent to which this paper has been

ghost written and the extent to which

the data has been misrepresented by

the ghostwriter to make the safety

profile of the drug look

better and the efficacy profile of the

drug

looked better we don't really know that

but enormous a number of these medical

journals are

are dependent on publishing these

industry trials

and so some medical journal editors

um have gone public

and have stated you know that they're

aware of the problem

but then you also find uh medical

journal editors

showing up to these conferences

that are put on by publication planners

in other words the ghost writers and the

medical journal editors go to the same

conference and we've got the medical

journal

editors actively soliciting the ghost

written manuscripts

from the ghost writers to their journals

there was something that

you you mentioned in your both your

article and the book

about this concept of the pharma

companies

buying thousands of issues of the

journal and that that's another

incentive

right for the uh the journals to

accept these fraudulent papers can you

describe that

so that's another way in which the

medical journals have become enormously

dependent upon

revenue from the pharmaceutical industry

you have to realize that

a clinical trial on a blockbuster drug

published in a top medical journal with

the branding of a key opinion leader

and that key opinion leaders university

affiliation

is worth an enormous amount of money in

terms of

confidence let's say for example

they want to buy a million copies of

these reprints because it's a

blockbuster drug and the sales reps are

now going to go distribute

the reprints of this journal article

so now the journal is is obviously going

to become enormously

rich on the basis of the reprint

sales of the journal article

and and also today there's another

phenomenon

where journal articles uh have open

access

and uh that's replacing the model

of the reprint issue but it's the

pharmaceutical

industry that's paying for the open

access

did you participate in thought in the

vioxx stuff or you just studied it for

your paper

this is not a case i worked on so i

don't know in a lot of detail but i can

speak

briefly about

the the fact that there were um

problems that they knew about when they

were conducting their clinical trials

with regard to stroke and um

heart attack and in this

one particular case they had a

manuscript ghost written

where they downplayed uh heart attack

cases and

the professor

who put his name on this paper was then

confronted with

the fact that there were patients in

this trial that had died of heart

attacks and were

not in fact reported in the paper and

his response to this was well

i went with the data that merck gave me

so this i think is the essence of the

problem that i referred to before

where you've got a lead author on a

paper

who can't guarantee the content of the

paper that's been published in his name

why is that well it's because the data

is owned by

the pharmaceutical company and they

release it according to their

own interests what are adverse events

and how does ghostwriting help hide

adverse events well there are a number

of ways

in which marketing people

will slice and dice the data

once it has been sort of analyzed by the

statisticians

and that's you know a very sort of

tricky process

of statistics as to how all of this can

be manipulated

but the one sort of instance that's

discussed in my book

it has to do with coding

a coding is how you describe an adverse

event in terms of some particular kind

of term

so so let's say for example in the case

of a

particular clinical trial for an

antidepressant tested on children

you get lots of adverse events which

include

suicidal ideation suicidal gestures

suicidal attempts or even completed

suicides

this became a problem with regard to

antidepressants for children because we

got a black box warning from the fda on

that eventually

and the paper i'm thinking of in

particular which was study 329

which is now famous for

this particular little tactic what they

did

was they coded suicidality or suicidal

events as something they called

emotional liability so it was basically

hidden

in the coding and emotional ability

nobody even seemed to know what that

term even meant

but it basically means anything from

crying

on the one hand all the way to sort of

attempting suicide

what are the other common ways to

manipulate a study

that these you know these medical

communications companies do

on behalf of big pharma we talk about uh

the way in which a clinical trial

is uh from start to finish

uh you've got the design of the trial

and that might be done by

you know scientists who are recruited

maybe even the key opinion

leaders who were recruited at the very

beginning

in conjunction with the internal

scientists at the pharmaceutical company

then you have the conduct of the trial

which is typically outsourced

to contract research organizations you

know it's the big

uh complex

uh effort of the logistics of of running

the clinical trial and collecting the

data

and then you have the reporting of the

trial which is done

by the medical communications company in

conjunction with

the marketing people so you've got three

different

phases here and in my book what what i'm

describing with dr gerardini

is cheating at every different level

here

all right so let's go back to the design

you're asking about

how the manipulation

can be accomplished from the very

beginning in the way

in which trials are designed so there

are a number of ways

for example if you use

too high a dose or too low a dose

of the drug against complete placebo or

comparator drug you could rig the trial

to sort of get some of the numbers that

you want

and to adversely impact a competitor

drug right i mean

sometimes these these trials are done to

slander

a a rival drug exactly

exactly you know and so in that case uh

you've got a trial that's being

conducted for a marketing purpose right

from the very start rather than

a genuine scientific purpose because you

know what

what they're doing is trying to increase

their market share with the other

companies by showing competitor that

their drug

is more effective or more safe but

getting back to

uh the problem with the design and

the fiddling with the dosage it was a

very good example of this again in study

329

where there was a comparator drug called

imipramine

that was being compared against paxil

and placebo

and they used an enormous

high dose of omipramine which

subsequent sort of researchers have

called elephant doses

especially for children and what that

did was

make the side effect profile of paxil

look

better by comparison okay so here these

are two examples right both coming from

one particular study 329

of how in the design of the trial in the

coding

and in the dosage we can get right from

the very start

a manipulation of the science what

what's the next stage and how

can manipulation enter into the picture

there there's a question here

about the conduct of the trial in many

cases

as to how the data is collected

and if it's being done by a for-profit

third party that's at service to the

sponsor

namely the pharmaceutical industry they

want to produce results that the sponsor

wants so for right from the start

there's there's a kind of financial

interest

in the outcome here um now

in one particular case that's described

in our book we had an

unblinding that occurred in the in the

conduct of the clinical trial

now in this particular case there was a

drug called citalopram that was being

tested

on children and nine

of the participants in the trial became

unblinded okay so right from the start

we've got a serious protocol violation

here

because what we're trying to do is a

double-blind

placebo-controlled clinical trial they

were dispensed

the pink commercial tablets by accident

instead of the pills which would

uh been indistinguishable as to placebo

and the study drug which was citalopram

in this case

now what we discovered again this is

only discovered through

the sort of discovery process of

litigation where we get access to all of

these documents

what we discovered is that the company

decided

to include eight of those nine

unblinded patients in the analysis of

the trial as

if they were not unblinded

you've got problems at all stages here

of design

conduct and reporting and in this case

the conduct and the reporting

there was a clear violation and

again doctors reading this medical

journal article

would be completely unaware of this we

see

what the incentive is to medical

journals because

they're taking pharma advertising and

they're getting

reprint dollars uh what about the

universities where

a lot of these physicians and you know

phds work

what's the incentive for them to be

involved in this fraud

i think universities just like the

medical journals are conflicted in the

sense that

there's an enormous incentive to to

to take in the revenue from

pharmaceutical companies

to conduct these trials at

university research hospitals for

example and

to have their university professors

participate

in drug testing now

one of the problems that we've found

with regard to

preserving the integrity of science is

that when things go badly wrong

and and then you go back to the

universities and you say

look this occurred under your watch you

need to do something about it

here is a ghost written medical journal

article that fraudulently

misrepresented the science it was your

university

professors who were the principal

investigators in this trial

and the first authors on this paper and

you need to take responsibility and

formally

acknowledge this and have

the journal article retracted

in other words encourage the retraction

from the journal that published it

and what we basically find they're

silent

let's talk about disease mongering

define that for us

disease mongering is another

term for selling sickness there was

a um pharmaceutical

executive in fact a ceo i think it was

from merck

he was reflecting on his career

on what he could have done better and he

said you know the main problem is that

we were

selling drugs to sick people what we

should have realized

is that we should sell drugs to healthy

people that way we've enormously

expanded our market and we could sell

drugs just like bubble gum

what has happened in something like the

past

20 or 30 years is that we're sold a lot

pharmaceuticals where the risk benefit

ratio

is not in favor of taking the drug

and we have all sorts of uh instances

where

people who really didn't need to be on

these drugs took these drugs

and then had serious adverse events

so disease mongering is a marketing

scheme

of pharmaceutical companies to

persuade us to use fear

and to use our trust in science and

extremely deceptive

way in order to persuade us to go on

on different kinds of drugs a lot of

people are just going to sort of trust

well it's a drug put out by a

pharmaceutical company it must be safe

and effective it's been approved by the

fda

and so people take the drug

for example a case like like gardasil

which is a vaccine

has been given to girls and you know

the company called merck engages

marketing pr firms to produce these

campaigns that appear on television

called

one less and these are entirely

persuasive to people who

fear cervical cancer

each year in the u.s thousands of women

learn they have cervical cancer

i could be one less one less statistic

one less because now there's gardasil

the only vaccine that may help protect

you from the four types of human

papilloma virus that may cause 70

percent of cervical cancer

but now it turns out that something like

pap smear testing

is enormously effective and basically

does the job

cervical cancer turns out to be have an

incidence it's extremely rare

but now we get cases where patients have

been

severely harmed by taking this

vaccine and end up in wheelchairs for

the rest of their lives

now this is a case where we've got the

pharmaceutical marketing which is out of

control we've got in

instances here where disease mongering

has has become a serious problem

i have cervical cancer from an infection

human papillomavirus who knew hpv could

lead to certain cancers

who knew my risk for hpv would increase

as i got older

who knew that there was something that

could have helped protect me from hpv

when i was 11 or 12

way before i would even be exposed to it

did you know

mom dad

[Music]

well that does suck like not being able

play sports anymore

because i did i did do a lot of sports

my favorite

this is an nj tube what it does is

basically

it goes up my nose and near my throat

and it goes past

my stomach into my jejunum or the first

part of the

small intestine because my stomach is

completely paralyzed

she got the third shot within two weeks

she was hospitalized and she remained

hospitalized

for eight solid months so they put her

on an immunosuppressant and a

uh intraconocell which is a anti-fungal

medication

i've dumped some of them out this is

what it looks like to be on gardasil

the after the aftermath of it and this

is just one bag we got about 15 more at

home

after all the struggles and fights and

we thought she was finally getting a

little better

she went to sleep she wasn't feeling

good during the day

and i wanted to check on her and she

looked like she was very still she was

in her bed

and she had passed away and i tried to

revive her

but she was gone i loved her so much i

would have

given my life first

she was just a good kid

and her mom made a bad choice

you know there are there are drugs that

that treat

very serious problems here that's a a

whole different matter

what we're talking about is is marketing

campaigns

that are designed to mold and shape

public

perceptions and to use fear in a very

sort of

effective way to

persuade patients to go to their doctors

insist

that they must have these drugs what

will you say don't wait

talk to your child's doctor today learn

more at hpv.com

now let me ask you what's the role of

the

fda the cdc the nih of

regulatory bodies uh and scientific

agencies

in this whole kind of charade to what

degree do they participate

well that's the first thing that most

people think about when

when they when they hear um

about the kind of fraud and corruption

that i'm talking about in the

pharmaceutical industry

they said well wait a minute we've got

the fda and the fda is

is one of the most respected regulatory

agencies in the world

uh so how is it possible that what

you're saying could be true

and now we have the phenomena of

regulatory capture where regulators are

captured by the industry that they're

supposed to regulate

in terms of different kinds of

legislation

that is introduced that are basically

gifts to the pharmaceutical industry

from

the senators and congress people who

are lobbied for such favorable

legislation and in these cases what we

have

is a regulatory capture

is that the industry becomes a client

to the regulators so we're not really

dealing with

sort of rigorous oversight anymore first

we continue working with the business

community to get more drugs approved

faster i'd like to ask the congressman

now to join me up here so we can sign

the bill thank you

and the other problem is called the

revolving door

where you've got regulators and

industry executives that just go back

and forth between the pharmaceutical

industry

and the fda

what do you say to people who say well

you know only

industry executives are you know

competent enough or know enough about

the industry to become

regulators well i don't think that

that's true

i mean i think that you know you could

have

uh serious epidemiologists

who are working at universities

uh who would be more ideal for these

roles

and do we have cases where someone

has just been say the head of you know

some branch of the cdc or uh

fda and then has moved directly

into an industry position where they had

literally

just helped along the approval of a

given drug and

are now you know a vice president at the

at the company who received the benefits

of that approval

you're exactly on target and that's

discussed in my book when we talk about

the case

of uh forest laboratories

citalopram and the very individuals

in the fda who gave the drug

or its

metoo molecule regulatory approval for

use in children

and when then what we find is that these

people

when they when they retire from the fda

after having approved the drug

they become a consultant for the very

company

that is going to benefit from that what

you're describing

what we've been talking about and the

nature of the work you've been doing

um has been medicine and pharmacology

in the best of times so now we're in a

situation

you know an alleged an emergency uh and

and

and drugs are uh you know are being

rushed to market without animal

trials uh so what how would you describe

uh the state of you know the response to

uh covet 19. well i'm

i'm terribly worried about this uh for

people who are who are taking this

vaccine right now who are at the front

lines

because it it has been rushed

to a market so quickly

uh that it it is it is it is alarming

and i think you know just as you said uh

if you look at if

if the way in which the testing goes on

in the best of times

uh you have every reason in the world to

be extremely

skeptical about what drugs you take and

about

whether or not you are receiving

uh the results of genuine science or

marketing

and now you have to imagine under the

worst of times namely a global pandemic

and um what we've got is a situation

where

it's extremely difficult for the top

scientists around the world to follow

the science

when you're getting so many

contradictory conclusions and results

what kind of trust and confidence are we

willing to put in this

now obviously you know we're just going

to have to wait and see

we're we're uh in the middle of all of

this at the moment

but it's an interesting question as to

whether or not the pharmaceutical

companies are

going to make this data available to

researchers

who might be interested in re-analyzing

it and attempting to determine just

exactly

what the effectiveness and safety

results were

final question what would evidence-based

medicine look like and how do we get

back

to doing it oh brilliant yeah

well i think that what we first of all

need to do

is to completely uh eliminate

um pharmaceutical companies testing

their own drugs

i mean how in the world we get into a

situation where we actually

trust the manufacturers to do their own

testing

[Music]

the oligarchy corporations here

has basically usurped democracy

the sort of uh cherished institutions of

democracy which involve

checks and balances in the system uh

but also scientific integrity

so who's looking out for scientific

integrity here's the problem

is it possible that covid19 is the

largest and most sophisticated disease

mongering campaign in human history

would say that we should approach this

with extreme skepticism

america's biopharmaceutical companies

have one very important thing in common

a common enemy we're making great

progress because we're collaborating in

ways that we've never done before

in a matter of weeks we've progressed

from potential treatments to antibodies

and antivirals that have shown positive

results to several promising vaccine

candidates

because science science science is how

we get back to normal

[Music]

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