Transcript Is Pharma different from organized Crime? Who steals more? Who kills more? Who bribes more? Which one neutralizes its opponents? Which one has higher ethical.

Is Pharma different from organized Crime?
Who steals more?
Who kills more?
Who bribes more?
Which one neutralizes its opponents?
Which one has higher ethical standards?
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Neutralizing the Naysayers
To silence the voices of leading doctors who
speak against drugs:
• Use “task force” to bring over to the other
side; neutralize
• Bribe with funding
• Ruin reputation; Discredit
• Gotti is a piker
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Neutralize
Dietz, Frederick
NEUTRALIZED
3
Neutralize
… spoke for us but has been less than enthusiastic
during talks
… Managed care group (PCS) is definitely not
Merck friendly
… Not totally anti-Merck but feels that Merck
overprices their drugs especially if we feel we have
a superior product
… PCS is the big fish in Rockford and, if VIOXX is
not put on formulary, there will be little market
share gained
4
Neutralize
Now an Advocate;
clinical trials
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Bribe
Altman, Roy
6
Bribe
… very poor relationship with us, dating back to the early
1980s
… a task force has been formed to try and bring him back to
neutral in his perception of us
… bad feelings from FOSAMAX, but wants to be perceived as
non-biased
… recommend a brainstorm with local reps, OSRs, and A&A
specialists for tactics and may also try Jim Kessinger (past
Fosamax launch manager covering Altman) for ideas;
Provide OARSE funding every year
7
Bribe
“Show me the money” – Clinical Trials
-Funding >$50,000 Rheum Fellowship Program
-Task Force to continue to work with him
-Task force in place – Dr. Bruce Freundlich, SBD (J.G.)
RMD K. Edward, M. Halpin & local reps
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Discredit
MacMillan, James
DISCREDIT
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Discredit
...speaking extensively for Searle/Pfizer (200 days this year)
… numerous reports of biased and inaccurate presentations
… gathering information on VIOXX from the Internet
… one of Searle’s most frequently used speakers across the nation (and loyally
devoted)
… loose cannon
… no way to win him over and frankly would not want this type of person
speaking for my product
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Discredit
Strong recommendation
to discredit him.
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Is Science different from
Religion?
Assuming arguendo that medicine
is in part based on science
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Is Science different from
Religion?
We Got Rules
We Got Priests
(high Priests too)
We Got Monasteries
We Got Beliefs
We Got Biases
What is the demarcation?
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WE GOT Cochrane!!!!
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Cochrane MI Treatment Study
In CCU
Deaths 6
Red to stop trial
Home
8
Green to continue
Yellow for the armadillos
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‘I showed it to some of the consultants
before the meeting and there was an
absolute uproar.’
‘that trial is unethical, it must be stopped’.
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On Bias
so I let them go on a bit and blow their
tops, and when they were calming down a
bit I apologized that I had shown them the
wrong table. I then showed them the
correct table, and said didn’t they think it
was unethical to continue with coronary
care units, but I was unable to convince
them . . . it does make the point that there
is an enormous amount of emotion about
coronary care units.
Red if bias different
Green to agree
Yellow for the armadillos 17
The Big Sellers
•
•
•
•
•
Nifedipine
Avandia
Vioxx (celebrex)
Ketek
Vytorin
Why were (are) these big sellers?
Think bias.
What else is interesting about these treatments?
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What’s the Bias?
19
Primum non Nocere
A1-c is a surrogate for this endpoint
Just like the Vioxx patients who died without joint pain and
The nifedipine patients who died with normal blood pressure and
The Seldane patients who died without stuffy noses
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Does this have anything to do with
drug trials?
What?
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Manipulating You
•
•
•
•
•
•
•
Manipulating the data
CME
Ghost writing
Persuasion
DTC
PR
Bribes
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Manipulating Studies
• Martin Keller at Brown University:
Efficacy of Paroxetine in the Treatment of
Adolescent Major Depression: A Randomized,
Controlled Trial
(Journal of the American Academy of Child and
Adolescent Psychiatry, July 2001)
23
Continuing Medical Education
• Half of all CME courses are
sponsored by pharmaceutical
companies
• Drug-industry financing of
continuing medical education
has nearly quadrupled since
1998, from $302 million to
$1.12 billion.
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On Persuasion
The rule of reciprocity
25
The influence of drug reps
The study:
A group of students were given 2 different surveys.
• An elected official who awards contracts accepting a
$50 gift from a prospective bidder.
• A medical student accepting a $50 gift from a drug
company.
Nurse practitioners were given similar questionnaires.
Is this Wrong?
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The influence of drug reps
The results:
The Medical Students:
• Public official’s
• Medical student
The Nurses:
• Nurse Practitioners
• Resident
• Nurse
85% Wrong
46% Wrong
97% Wrong
64% Wrong
30% Wrong
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Pens and Pencils Matter
Ad from Pharmaceutical
Executive magazine
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Pens and Pencils Matter
“If the pens were handed out to 50 docs
per rep or 100,000 docs, then each doc
would have to bring in a mere $0.15 worth
of new scripts to cover the cost. Say,
however, that only 2% 0r 2,000 docs that
were given pens are subject to gift
influence peddling -- the other 98% of
docs threw their pens in the waste basket.
These easily-influenced docs would then
would have to write $2.00 more scripts for
the drug than they normally would to make
the pen project break even for the pharma
company. That seems like a realistic
scenario. “
-from the Pharma Marketing Blog
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The influence of drug reps
SKIP
The study:
The Kaiser Family Foundation national survey of physicians, conducted
in 2001 with a sample of about 2600
The results:
• 15% rated info from drug reps as “very useful,”; 59% as somewhat
useful
• 9% rated that info “very accurate,”; 72% “somewhat accurate”
• 92% had accepted free drug samples; 61% had accepted meals, free
travel, or tickets to entertainment events; 12% had received “financial
incentives to participate in drug trials.
• 31% thought it was unacceptable for reps to receive information about
prescribing habits; 43% said they were bothered by it but understood
its purpose; 22% had no problem with the practice.
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The influence of drug reps:
Patient Awareness and Attitude toward
Commercial Gifts
Gift
% aware of gift
% who don’t
approve
% who approve
% with no
opinion
Dinner
22.4
48.4
34.6
14.6
Baby formula for
family use
28.6
44.2
41.4
10.9
Cocktail Party at
Conference
Not asked
43.4
40.5
13.0
Golf tourn. at
conference
Not asked
41.6
40.3
14.6
Coffee Maker
13.8
40.7
39.1
17.3
Conference
expenses
Not asked
32.5
52.7
11.5
Ice cream at
convention
Not asked
28.0
55.6
12.8
Ballpoint Pens
55.3
17.5
67.3
13.0
Medical Books
34.6
16.9
70.0
9.9
Drug Samples for
office use
87.0
7.6
82.1
9.3
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Ghostwriting
According to recent studies in JAMA and the British
Journal of Psychiatry, between 11% and 50% of
articles on pharmaceuticals that appear in major
medical journals are ghostwritten.
32
Disease Mongering
“The desire to take medicine is
perhaps the greatest feature
which distiguishes man from
animals”
-Sir William Osler
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How to Disease Monger:
A Summary
It takes 8 years to bring a drug from the
lab to the pharmacy, and less than 18
months to obtain a new indication.
How to sell a sickness:
• Step 1: Create a new condition, redefine an
existing condition to reduce the stigma, or
elevate the importance of an existing
condition.
• Step 2: Market the symptoms instead of
the drug.
• Step 3: Offer pills to cure the disease
You have a blockbuster!
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Case Study: Social Anxiety
Disorder (SAD)
• Once a little known condition. According to
DSM4: “extrermly rare,” 1-2%
• GSK hired public relations firm to position SAD
as a severe condition”
• Expand disease : Bus & Metro Ads
• Supported by Social Anxiety Disorder Coalition,
APA, Anxiety disorders of America Foundation,
Freedom from Fear
• PR:
– Video news release
– Standard release with names of paid
consultants
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Case Study: Social Anxiety
Disorder (SAD)
• SAD became a media frenzy in 1998 just
after Paxil was approved to treat the
condition
• The slogan? "Imagine Being Allergic to
People."
• SAD was positioned as the third most
common psychiatric disorder in the U.S.,
affecting 13.3% of the population.
Today, Paxil is the #2 selling SSRI, behind
Eli Lilly’s Prozac.
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Case Study:
Lunesta
• Press releases encourge articles about sleep problems years before
approval
• 2001-2003: 600 articles on sleep problems
• 2003-2005: >1000
• Duke site of trials release press releases before approval, which mention
drug
– “Sleepless at Duke find cure” - Raleigh News & Observer
• Seeding trials ???
• Astro-turf National Sleep Foundation
–
–
–
–
Big Pharma funded at least 1.2 million per year plus “Poll”
1996 ½ Americans suffer frequent insomnia & sleeplessness
Under recognized, under-diagnoses, under-treated
2005 75% sleep problems so bad it interferes with sex
• Thought leaders
• APA support
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Case Study:
Lunesta
Approved in May 2005. The next steps in the
plan of attack:
•
•
•
•
60 million DTC coming out ad during Desperate Housewives
“Lunesta helps most people sleep all through the night.”
“the first and only prescription approved for long-term use.”
CFO: “Its a drug you can take again and again and again.
45 days later 60,000 new scripts per week
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Other mass-marketed disorders:
• Premenstrual dysphoric disorder
(PMDD)
• Female sexual dysfunction
• Irritable bowel syndrome (IBS)
• Attention deficit disorder
• Generalized anxiety disorder (GAD)
• Restless leg syndrome
• Persistent genital arousal disorder
(PGAD)
And the list goes on and on . . .
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Key Elements of Disease Mongering and how the
Media Could Do Better
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The Number Needed to Treat
Defined as the number of patients that
would require treatment with a form of
medication to reduce the expected number
of cases of a defined endpoint by one
It does not account for NNTHarm
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Would you take this for 5 years
if?
• Lowered your
chance of a heart
attack by:
• Lowered your
chance of having a
heart attack from:
• Saved 1/100 from
having a heart attack
33%
3% to 2%
Who will it be??
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Misleading Stats
Case Study: Lipitor
The Claim:
Lipitor “reduces the risk of heart attack by 36
percent…in patients with multiple risk factors
for heart disease.“
The Reality:
“in a large clinical study, 3 percent [or three out
of every hundred] of patients taking a sugar
pill or placebo had a heart attack compared to
2 percent [or two out of every hundred] of
patients taking Lipitor."
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Misleading Stats
Case Study: Lipitor
The Math:
• To spare one person a heart attack, 100 people
would have to take Lipitor for more than 3 years.
• Working with less than 100 pateints would
produce no benefits.
• You can’t help one-third of a person not have
a heart attack.
• A success rate of one out of 100 means that
“the other 99 got no measurable benefit” from
Lipitor.
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The Number Needed to Treat
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Prevention vs. Care
Does prevention really save money?
A recent study, lead authored by Joshua T. Cohen and
published in the NEJM says no:
• About 19 percent of prevention strategies saved money
right off the bat, compared to 18 percent of the treatment
strategies.
• About 48 percent of prevention strategies saved lives for
less than $50,000 per QALY compared to 50 percent of
treatment strategies.
But this is only one interpretation of the data.
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Prevention vs. Care
A different analysis, using the same data, finds:
• According to economics literature, there are 4 times as
many medical treatments being offered patients today that
are not cost effective as there are prevention strategies that
are not cost effective.
• Indeed, over 80 percent of treatment interventions cost
more than they save, just as over 80 percent of prevention
interventions cost more than they save.
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Prevention vs. Care
• Big Pharma beneftis from promoting care as a better
solution. More diseases to treat, more money spent on
drugs and interventions.
• Dr. Cohen, through his prior work at the Harvard Center for
Risk Analysis has conducted research for numerous
industrial groups, including housing (lead in children),
telecom (cell phones and driving) and food (mercury and
fish). The Tufts Center where he now works has received
unrestricted educational grants from numerous drug
companies.
• Was the data spun to show a bias in favor of care and
support a corporate agenda?
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Other Challenges to Drug Safety
•
•
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•
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•
•
•
•
Controlling the FDA
Off-label marketing
DTC marketing
Pens & pencils matter
Astroturf (fake grassroots organizations)
Control of real grass roots groups
Funding of research
Funding consensus groups
Fake ethics
49
Drugs withdrawn for safety reasons,
1980 - 2005
Drug
Approved
Therapueitc Class
Rating*
Approval Phase (yrs)
Zomax (zomiperac)
1980
NSAID
P
1.9
Oraflex (benoxaprofen)
1982
NSAID
S
2.2
Merital (nomifensine)
1984
antidepressant
S
6.0
Suprol (suprofen)
1985
NSAID
S
7.2
Seldane (terfenedine)
1985
Antihistamine
P
2.2
Enkaid (encainide)
1986
antiarrythmic
P
2.9
Hismanal (astemizole)
1988
antihistamine
S
3.8
Omniflox (temafloxin)
1992
antiinfective
S
2.2
Manoflax (flosequinan)
1992
Vasodilator
S
2.2
Propulsid (cisapride)
1993
gastrointestinal
S
1.9
Duract (bromfenac)
1997
NSAID
S
2.5
Posicor (mibefradil)
1997
antihypertensive
S
1.3
Raxar (grepafloxacin)
1997
Antiinfective
S
1.0
Trovan (trovafloxacin) **
1997
Antiinfective
S
1.0
Rezulin (troglitazone)
1997
Antidiabetic
P
0.5
Baycol (cerivastatin)
1997
Statin
S
1.0
Raplon (rapacuronium)
1999
Anesthetic
S
1.1
Vioxx (rofecoxib)
1999
NSAID (Cox-2)
P
0.5
Lotronext (alosetron)**
2000
Gastrointestinal
P
0.6
Bextra (valdecoxib)
2001
NSAID (Cox-2)
S
0.8
P=Priority Review, S=Standard Review **Subsequently re-introduced to the market with restricted labeling
50
The Big Picture
• Medical education is designed to reproduce the
profession, which is of course the sale of drugs
& medical devices & medical procedures.
• That is why medical education focuses on NEW
patent drugs and not behavior change, exercise,
physical therapy or vitamins (like folic acid,
which is very effective at reducing MI risk).
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"Values are always with us...There
can be no view except from a
viewpoint. Prior to answers there
must be questions. In the questions
raised, the viewpoint has (already)
been chosen and the valuations
implied."
-- Gunnar Myrdal
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