Transcript Is the relationship between the industry and prescribers (doctors) in

Is the relationship
between the industry
and prescribers
(doctors) in trouble?
Richard Smith
Editor, BMJ
www.bmj.com/talks
Answer
•It could certainly
be improved-made more
“professional”
What I want to talk about
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A story of trouble
The context of the relationship
How is the world changing?
Another story of trouble
What are the current relationships
between doctors and industry?
Conflicts of interest: a case study of
entanglement
How might the relationships between
doctors and industry be improved?
Another story of trouble
Conclusions
A story of trouble I
• AstraZeneca’s tactics in promoting
rosuvastatin "raise disturbing questions
about how drugs enter clinical practice
and what measures exist to protect
patients from inadequately investigated
medicines"
• The Galaxy series of clinical trials,
which investigated the efficacy of
rosuvastatin, included "weak data,"
"adventurous statistics," and
"marketing dressed up as research,"
• It has been an "unprincipled campaign"
• Richard Horton, editor, Lancet
Lancet 2003;362: 1341
A story of trouble I
• Regulators, doctors, and patients
as well as AstraZeneca have been
poorly served by your flawed and
incorrect editorial. I deplore the
fact that a respected scientific
journal such as The Lancet should
make such an outrageous critique
of a serious, well studied, and
important medicine
• Tom McKillop, CEO, AstraZeneca
The context
• Virtually all new drugs in the
past 50 years have been
discovered or manufactured by
the drug industry
• The industry has consistently
been one of the most profitable
industries and is truly global
• It has great political power,
particularly in the United States
The context
• Medicine is also global, but there is
no international “health
organisation” (WHO, WMA) that has
the resources and power of the
industry
• Research-based companies are
merging--driven in large part by the
costs of discovering new drugs and
bringing the to market
The context
• The power of generic
companies (many in India and
Brazil) is rising
• The cost of bringing a drug to
market is huge and rising-which may be no bad thing for
large companies as it raises
“the barrier to entry”
The context
• The industry has been largely cut
off from the people who take their
products
• The industry has concentrated its
enormous marketing resources on
doctors--because they have written
the prescriptions
• The “spend” per doctor is
enormous
• Doctors have become addicted to
the largesse
The context
• Companies must produce a good
return on investment for
shareholders
• They ideally do this through
producing much needed new drugs-from which everybody benefits
• But their legitimate commercial
values sometimes (even often)
conflict with the values of health
care workers and systems
The context: examples of
value clashes
• It cannot make commercial sense
to produce new drugs for very rare
conditions or conditions affecting
those who have no money to pay
• It does make sense to produce a
“me too” drug for a profitable
market and market it as hard as
possible
• Restrictions on marketing efforts
are legitimately strained against
The context: examples of
value clashes
• Drug treatments are favoured over nondrug treatments
• Companies are understandably
reluctant to fund large head to head
trials
• Companies are clever enough to
“honestly” get the results from trials
they fund
• Companies favour secrecy for
commercial reasons; doctors and
patients want transparency
The world is changing
• Drug companies have a
productivity crisis--companies
were producing 3 new chemical
entities each year on average;
now it’s 0.3 (Dresdner Kleinwort
Wasserstein)
• In these circumstances
companies may need to market
still harder the products they
have and “invent” new diseases
The world is changing
• The current business model of researchbased companies is unsustainable-Dresdner Kleinwort Wasserstein
– New discoveries are down
– 12-15% increase in sales (half of it
coming from price increases) is
becoming impossible to sustain because
of political pressure (4th hurdles, NICE,
etc)
• Answer: more mergers, creating
“monopolies” in particular therapeutic
areas
The world is changing
• Direct to consumer advertising has
arrived in the US and New Zealand and
will probably be unstoppable across the
world
• Companies have to increase their
marketing spend dramatically
• New “relationships” are created with
consumers
• Doctors generally resent companies
“going over their heads” and creating
expectations that doctors must meet
The world is changing
• Increasing numbers of bodies—
for example, NICE and HMOs—
are interested in controlling
prescribing
• A WHO report praises NICE but
criticises it for being too close
to industry
• Other prescribers are appearing
• Doctors may not be the target
they once were
The world is changing
• There is growing understanding of
how the industry can get the
results it wants—three papers for
the Christmas BMJ
• Governments are increasingly
interested in public funding of
trials
• ALLHAT and the Women’s Health
Initiative have given that interest a
boost
Trouble 2
• A journal publishes a paper that
combines two trials A and B that
show that a drug manufactured by Y,
the sponsors of the studies, is better
than a drug manufactured by Z
• A correspondent points out that trial
A has already been published—a
case of duplicate publication?
• Trial A and the paper (A and B) had
only one common author—an
employee of Y
Trouble 2
• It also emerges that trial B did
not find that Y had better
outcomes than Z
• Then it emerges that on the FDA
website the trials A and B both
included other outcome
measures—possibly ones that
matter more to patients—where
Z had better outcomes than Y
• How should the
editors/publishers respond?
What are the
current
relationships
between doctor
and industry?
16 forms of entanglement
between doctors and drug
companies
• Face to face visits from drug
company representatives
• Acceptance of direct gifts of
equipment, travel, or accommodation
(“Will you advertise my drug on your
person for a year if I pay you 20p?”)
• Acceptance of indirect gifts, through
sponsorship of software or travel
16 forms of entanglement between
doctors and drug companies
• Attendance at sponsored dinners and
social or recreational events (“If they
have to pay the full whack they won’t
come?”)
• Attendance at sponsored educational
events, continuing medical education,
workshops, or seminars (“Could you
hurry up so we can get to the vol au
vents?”)
• Attendance at sponsored scientific
conferences (“Bugger Bognor, but the
Gritti Palace in Venice sounds good.”)
16 forms of entanglement between
doctors and drug companies
• Ownership of stock or equity holdings
• Conducting sponsored research (“It’s
so hard to get money from the MRC and
£800 for registering a patient is not
bad.”)
• Company funding for medical schools,
academic chairs, or lecture halls
• Membership of sponsored professional
societies and associations
• Advising a sponsored disease
foundation or patients' group
16 forms of entanglement between
doctors and drug companies
• Involvement with or use of sponsored
clinical guidelines
• Undertaking paid consultancy work for
companies (“A return flight on Concorde,
five nights at the Ritz Carlton, and 20
grand is not bad for two hours of blah.”)
• Membership of company advisory boards
of "thought leaders" or "speakers'
bureaux” (“Flattery and money: I can
resist everything except temptation.”)
16 forms of entanglement between
doctors and drug companies
• Authoring "ghostwritten" scientific
articles (A critic on Naomi
Campbell’s autobiography: “If she
can’t be bothered to write it I can’t
be bothered to read it.”)
• Medical journals' reliance on drug
company advertising, company
purchased reprints, and sponsored
supplements (“It’s a million quid and
£800 000 profit for reprints of a
major trial. Without it I might have to
lay off staff. But we’re not influenced
in our decision making.”)
Does all this matter?
• Virtually all new drugs, which
have been so important for
medicine, have come from drug
companies
• Drug companies must have the
right to market their products
• Prescribing is influenced--often
to be unnecessarily expensive
Does all this matter?
• Information is biased
• Doctors are too dependent on
drug companies for both
education and information
• Companies spend more on
marketing than on research
• Costs are inflated