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?. Neutralizing the Naysayers. To silence the voices of leading doctors who speak against drugs:
Who steals more?
Who kills more?
Who bribes more?
Which one neutralizes its opponents?
Which one has higher ethical standards?
To silence the voices of leading doctors who speak against drugs:
… 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
Now an Advocate; clinical trials
… 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
...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
Strong recommendation to discredit him.
Assuming arguendo that medicine is in part based on science
We Got Rules
We Got Priests (high Priests too)
We Got Monasteries
We Got Beliefs
We Got Biases
What is the demarcation?
Red to stop trial
Green to continue
Yellowfor the armadillos
‘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’.
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 biasdifferent
Yellow for the armadillos
Why were (are) these big sellers?
What else is interesting about these treatments?
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
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)
The rule of reciprocity
A group of students were given 2 different surveys.
Nurse practitioners were given similar questionnaires.
Is this Wrong?
The Medical Students:
Ad from Pharmaceutical Executive magazine
“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
The Kaiser Family Foundation national survey of physicians, conducted in 2001 with a sample of about 2600
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.
“The desire to take medicine is perhaps the greatest feature which distiguishes man from animals”
-Sir William Osler
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:
You have a blockbuster!
Today, Paxil is the #2 selling SSRI, behind Eli Lilly’s Prozac.
Approved in May 2005. The next steps in the plan of attack:
45 days later 60,000 new scripts per week
And the list goes on and on . . .
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
3% to 2%
Who will it be??
Lipitor “reduces the risk of heart attack by 36 percent…in patients with multiple risk factors for heart disease.“
“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."
Does prevention really save money?
A recent study, lead authored by Joshua T. Cohen and published in the NEJM says no:
But this is only one interpretation of the data.
A different analysis, using the same data, finds:
P=Priority Review, S=Standard Review **Subsequently re-introduced to the market with restricted labeling
"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