What I found thought-provoking is that off-label promotion
(of pharmaceutical companies) can be prosecuted as a criminal offense. That is,
the attempt to influence physicians’ prescribing behavior using good or bad,
but not “officially” approved information is a criminal act. [Remember, when
the pharma promotes their drugs, off or on label, their intent is to influence
doctors, who ultimately prescribe these drugs. That is, in the final analysis, if
the patient is harmed/helped by (in)appropriate administration of treatments,
it is because of the act of physicians].
I
was a bit surprised that a few people commented on this (perhaps, due to pre-holiday
fervor?) The reason that I find this so interesting is that it has tremendous
implications for the way we practice medicine (and EBM). Physicians are free to
prescribe whatever treatments they want as long as they believe that it will do
more good than harm to their patient(s), regardless, if the administration of
the drug is “off label” or “on label”. In fact, in my own field (hem-onc) it is
estimated that up to 70% of treatment prescription is “off label”. So, what
does it mean when individual physicians prescribe treatment, which is “off
label”? Should we be criminally prosecuted? Which brings me to the question for
this group: should we only accept the use of “on-label” indications as
evidentiary standards for the practice medicine?
Ben
From: Evidence based
health (EBH) [mailto:[log in to unmask]] On Behalf Of Ash
Paul
Sent: Thursday, December 23, 2010 2:17 AM
To: [log in to unmask]
Subject: Re: What are the Implications for evidenced-based medicine when
physicians use drugs off-label?
Dear Roy,
In a natural
continuation of your superb blog, there has been another great piece of
writing recently , this time from Michael Millenson, writing
in Kaiser Health:
'No Outrage,
No Story in Dead Patients'
When I
have commissioning arguments with clinicians, they nearly always throw
back the Hippocratic oath at me (emphasising the ethics of preserving
doctor-patient autonomy). Many of them have all but forgotten that the
first caveat in that oath is 'Primum Nom Nocere' (First Do No Harm)!
Here's
wishing you and everybody else in the Group a merry Christmas and a very happy
2011.
Regards,
Ash
Dr Ash Paul
Medical Director
NHS Bedfordshire
21 Kimbolton Road
Bedford
MK40 2AW
Tel no: 01234897224
Email: [log in to unmask]
From: "Poses, Roy"
<[log in to unmask]>
To: [log in to unmask]
Sent: Tue, 21 December, 2010 22:42:35
Subject: Re: What are the Implications for evidenced-based medicine when
physicians use drugs off-label?
I wrote about this on Health Care Renewal here:
http://hcrenewal.blogspot.com/2010/12/drug-companies-are-now-no-1-when-it.html
My concluding sentence was: "True reform will require holding health
care organizations to higher, not lower standards than trash haulers and
gambling casinos, and regarding working in health care as a calling, rather
than a means to satisfy one's greed."
On Sun, Dec 19, 2010 at 5:18 AM, Ash Paul <[log in to unmask]>
wrote:
Dear
colleagues,
Ben
(Djulbegovic) has requested that I throw this question open to the
Group following a private email conversation I was having with him over
the recent publication of this report by Public Citizen, which is a
nonprofit consumer advocacy organization based in Washington, D.C. (www.citizen.org).
In
his email to me, Ben wrote:
This
is really amazing - I was not aware that a) the single largest category of financial
penalties, stemmed from the practice of off-label promotion of pharmaceuticals
and b) Off-label promotion can be prosecuted as a criminal offense
.....................
To
read the full report, visit http://www.citizen.org/hrg1924.
Dec. 16,
2010
Pharmaceutical
Industry Is Biggest Defrauder of the Federal Government Under the False Claims
Act, New Public Citizen Study Finds
Civil,
Criminal Settlements Have Increased Dramatically; Off-Label Promotion Largely
Responsible
WASHINGTON,
D.C. – The drug industry has now become the biggest defrauder of the federal
government, as determined by payments it has made for violations of the False
Claims Act (FCA), surpassing the defense industry, which had long been the
leader, according to a new Public Citizen study released today.
The study
found that pharmaceutical cases accounted for at least 25 percent of all
federal FCA payouts over the past decade, compared with 11 percent by the
defense industry.
The fraud
results were a key finding from a Public Citizen analysis of all major
pharmaceutical company civil and criminal settlements on the state and federal
levels since 1991 and found that the frequency with which the pharmaceutical
industry has allegedly violated federal and state laws has increased at an
alarming rate. Of the 165 pharmaceutical industry settlements comprising $19.8
billion in penalties during the past 20 years, 73 percent of the settlements
(121) and 75 percent of the dollar amount ($14.8 billion) have occurred during
the past five years.
Many of the
infractions, and the single largest category of financial penalties, stemmed
from the practice of off-label promotion of pharmaceuticals – the illegal
promotion of a drug for uses not approved by the Food and Drug Administration
(FDA). Off-label promotion can be prosecuted as a criminal offense because of
the potential for serious adverse health consequences to patients from such
promotional activities. Another major category of federal financial penalties
was purposely overcharging for drugs under various federal programs, which
constitutes a violation of the FCA.
On the
state level, the largest category of financial penalties has come from
companies deliberately overcharging state health programs, such as Medicaid.
Public Citizen’s study found this to be the most common category of violation
among state settlements.
The
increase in payments for fraud is likely attributable to drug companies
engaging in more wrongdoing and better enforcement at the state and federal
level, said Dr. Sidney Wolfe, director of the Health Research Group at Public
Citizen.
“Desperate
to maintain their high margin of profit in the face of a dwindling number of
important new drugs, these figures show that the industry has engaged in such
activities as dangerous, illegal promotion for unapproved uses of drugs and
deliberately overcharging vital government health programs, such as Medicare
and Medicaid,” said Wolfe. Wolfe compiled and analyzed the data with physicians
from the Johns Hopkins General Preventive Medicine program, Drs. Sammy Almashat
and Charles Preston, as well as Columbia University public health student
Timothy Waterman, all of whom worked at Public Citizen.
Public
Citizen’s study also found that more than one-half of the industry’s fines were
paid by just a few companies – GlaxoSmithKline, Pfizer, Eli Lilly and
Schering-Plough. These four companies accounted for more than half of all
financial penalties over the past two decades, paying $10.5 billion in fines
collectively. These pharmaceutical companies were among the largest in the
world. The two largest criminal penalties ever assessed by the U.S. government
against any companies were against Lilly ($515 million) and Pfizer ($1.2
billion), both in 2009.
To conduct
the study, Public Citizen created a database of information about
pharmaceutical companies’ civil and criminal settlements, including information
about the type of alleged violation and the amount of money paid in
settlements. This study is the first to attempt to document and analyze all
major pharmaceutical company settlements with both federal and state
governments, the authors said.
Nationally,
former pharmaceutical company employees and other whistleblowers have been
instrumental in bringing to light the most egregious violations; they have
initiated the largest number of federal settlements in the past decade. The
number of federal settlements arising from whistleblower cases has more than
doubled over the past five years, yielding total payouts more than two and a
half times higher than in the previous 15 years combined.
Needed
remedies include imposing steeper financial penalties and criminally
prosecuting company leadership, including jail sentences, if merited.
“The danger
to public safety and loss of state and federal dollars that comes with these
violations require a more robust response,” Wolfe said.
Regards,
Ash
Dr Ash Paul
Medical Director
NHS Bedfordshire
21 Kimbolton Road
Bedford
MK40 2AW
Tel no: 01234897224
Email: [log in to unmask]