Healthy Skepticism Library item: 19677

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Jack A
Letting the sunshine in on doctor-pharma relationships
BMJ 2011;
http://www.bmj.com/content/343/bmj.d6459.extract

Abstract:

Drug companies are increasingly obliged to publish details of payments to doctors. The United
States is leading the charge, but are we getting the full story in Europe?

When the drug company Cephalon took 13 British doctors to
the European pain congress in Lisbon in September 2009, the
expenses it provided did not stop with travel, fees, and
accommodation—and its presentations were not limited to a
balanced scientific explanation of its products at a day time
satellite meeting. An internal feedback document circulated to
the sales team at the company (now owned by Teva) described
one evening’s festivities that it funded for staff and doctors:
“Dinner was fantastic . . . we then went to a few bars and to a
club till 3am. All the customers were really looked after and
spoke positively about Effentora [fentanyl]—let’s make sure
they start Rxg [prescribing] now!”
It was a complaint from a former Cephalon sales representative
that triggered an inquiry by the Prescription Medicines Code
of Practice Authority, the self regulatory arm of the Association
of the British Pharmaceutical Industry. That led to a sharp public
rebuke for the company, while providing a rare public insight
into the tactics and motivations behind corporate links to doctors.
Such incidents—and many far more troubling and extensive
ones exposed and penalised through lawsuits in the US in recent
years—have led to increasingly tough codes of conduct being
introduced by drug companies around the world, and to calls
by politicians and regulators for far greater “sunshine” to
highlight their activities.
Similar pressures are now building in Europe. Since 2008,
Denmark has required companies to disclose to the Medicines
Agency any payments they make to doctors, and even details
of extensive “unpaid involvement” such as unremunerated work
on advisory boards.1 There have been calls for a similar approach
in the Netherlands, and politicians in France recently drafted
legislation that requires companies to release details of payments
to doctors, drafted in response to concerns over the marketing
tactics of Servier that were exemplified by the scandal around
its drug benfluorex.2
“I think sunshine in Europe is both desirable and inevitable,”
says Richard Bergstrom, head of the European Federation of
Pharmaceutical Industries and Associations, the Brussels based
industry trade body that represents companies across the EU.
But he stresses the need to take into account the varied
approaches and interactions between doctors and companies in
different countries.
US lead
With widespread direct to consumer television advertising of
medicines, free product samples, and extensive support of
continuing medical education, the US has led the world in the
aggressive marketing of pharmaceuticals. Not coincidentally,
it is now also leading the way in the provision of information
about such activities. Twelve drug companies have recently
begun publishing details on their websites of the payments they
make to physicians in the US, declaring payments or expenses
incurred for meals, travel, consulting, and research to each of
thousands of named doctors. While far from complete and
difficult to compare, the records are starting to reveal the extent
of the links between the two, and shifting practices as a result.
According to an analysis by the Financial Times, conducted
with the US based consultancy PharmaShine, in the first quarter
of this year alone payments amounted to more than $110m
(£71m; €84m).3 Last year, they totalled $437m, paid to 262 000
doctors across the country. Some doctors received more than
$100 000 each in 2010, and one got $234 000, most of which
was speaker fees from Cephalon.
The companies often claim they are championing an ethical
stance in releasing the data, and all stress that such links with
the medical profession are essential for the development and
uptake of innovative drugs to improve patient outcomes. In
practice, most have been forced to provide the information
because of legal settlements, often “corporate integrity
agreements” imposed by the Department of Justice. Some of
the large drug companies are yet to provide the data in the US,
including Shire, Sanofi, and Bayer. They point to the enormous
complexity and cost of compiling all the information from a
wide range of internal computer systems and the lack of any
legal obligation to do so. Yet companies will soon have no
choice. As part of President Barack Obama’s healthcare reforms,
putting “sunshine” on physician payments—fuelled by public
pressure and exposure of past practices—becomes compulsory
in 2013.
The new regulations may provide some much needed
consistency. Currently, each company has published different
types of data in different ways, making the information hard to
access or compare. The differences may reflect particular legal
requirements in each case reached in negotiations with
prosecutors, but they leave the impression that the companies
are doing their best to make the information as inaccessible as
possible.
Few allow their data to be easily searched, ranked, or extracted
for analysis. Each has different thresholds below which they do
not provide information. Some publish only ranges of support
rather than providing specific figures. Some companies’ figures
are inflated by the sums they provide in research funding to
prescribers’ academic institutions, while others are limited to
personal payments to doctors.
The result has been periodic and labour intensive efforts by
external organisations to make comparisons from the data.
ProPublica, a US non-profit journalism organisation, has
recently updated its analysis of the figures, “Dollars for Docs,”
which allows anyone to search by company, state, or doctor.4
The project, and the sunshine data on which it draws, has met
with mixed reviews. “Our once proud profession has been totally
corrupted by the insurance cartel and PhARMA [the US industry
association],” wrote one retired doctor on the ProPublica site.
“No longer is the Hippocratic Oath the ethical basis of medical
care . . . by [and] large making money has become the ideal.”
Yet others—both doctors and drug companies—defend the
financial connections, stressing that the payments to most
physicians are modest; that they can legitimately provide
information without distorting prescribing practice; and that
connections are essential between top disease specialists and
companies developing new drugs.
Eli Lilly said in a statement: “Lilly is committed to ensuring
that our relationships with healthcare providers are conducted
in a manner that complies with applicable legal and ethical
standards. Our collaboration with healthcare providers is
essential to our ability to provide innovative medicines, improve
health education, better understand patients’ needs and improve
individual patient outcomes.”
Behaviour change
It is difficult to tell what impact sunshine has had on drug
industry practices. Though the data remain incomplete and the
timescales are still short, some companies seem to be providing
less support than in the past. But the entire sector is also under
broader financial pressure to save costs by cutting back on
marketing expenses, reducing the number of sales staff they
employ in the US and cutting support to prescribers.
Following recent legal settlements, drug companies have also
introduced tougher ethical codes. Travel and entertainment
expenses have been pared back and the maximum value of gifts
sharply reduced. GlaxoSmithKline this year removed any direct
bonus for its sales staff linked to the volumes of prescriptions
by the doctors they target. AstraZeneca has introduced a ban
on paying doctors’ travel expenses to international medical
conferences.
Allan Coukell, head of the Pew Prescription Project, a US drug
safety watchdog, says: “Sunshine has certainly heightened
awareness of the concerns. Many individual companies have
changed this or that practice. I don’t think we have data yet that
really lets us say there are measurable trends.”
But there are already some indications of the impact of the
public data. With more information on the totals paid by
companies to physicians some have since set—or made
public—annual caps. Others have ceased payments to doctors
whom ProPublica has highlighted were the object of disciplinary
action.
George Dunston, founder of PharmaShine, which sells its own
constantly updated database derived from the disclosures, says
his clients include academic and medical institutions that are
keen to see whether the figures provided by industry tally with
the declarations made directly by their staff.
For now, the pressures for greater disclosure in the UK and
much of the rest of Europe have been more limited. The
principles to limit conflict are clear, but the evidence of abuse
is limited. In its 2009 report Innovating for Health, a working
party convened by the Royal College of Physicians concluded
that there was mistrust in the relationship between industry and
doctors and called for changes, including the elimination of
drug company funding of medical education.5
So far, progress has been modest. Article 74 of the General
Medical Council’s good medical practice guidelines states:
“You must act in your patients’ best interests when making
referrals and when providing or arranging treatment or care.
You must not ask for or accept any inducement, gift or
hospitality which may affect or be seen to affect the way you
prescribe for, treat or refer patients. You must not offer such
inducements to colleagues.”6 The body says it has no record of
any recent action against a doctor for violating this clause.
The UK’s Prescription Medicines Code of Practice Authority,
which polices a code of conduct that has been tightened
considerably in recent years, does periodically clamp down on
abuses, from Cephalon’s conference entertainment to Abbott’s
excesses in hiring lap dancers during an evening for prescribers.
It relies on tip-offs, which often come from rival drug companies
or former employees as well as prescribers. It has limited powers
of investigation, largely relying on cooperation and honesty
from those it questions.
In Scotland, doctors working for the health service are already
required to declare any conflicts of interest with drug companies,
although accessing—let alone policing—the information is
difficult. A parallel requirement by companies to disclose what
they are paying to prescribers would allow government officials,
health service administrators, patients, journalists, and
prosecutors the chance to compare the two sets of data.
Meanwhile, the external scrutiny of industry support for doctors
is stepping up. US investigators are now increasingly looking
to pursue cases under the Foreign Corrupt Practices Act that
take place beyond its own shores, including a $70m settlement
against Johnson & Johnson reached earlier this year. The UK’s
Corruption Act also scrutinises bribery within and beyond the
UK.
Vivienne Nathanson, head of science and ethics at the British
Medical Association, points to her organisation’s endorsement
of the industry code and stresses the importance of “making
sure there is as much declaration of interest as you can possibly
make.” She adds that she would “not object to more statutory
declarations, but given there’s already so much bureaucracy, so
much already declared, people want to make sure it is useful
and does not just cloud the issue.”
Companies seem resigned to greater transparency ahead, while
also cautioning about the costs of disclosure. David Brennan,
head of AstraZeneca, which has released data for the US
(showing payments of $32m last year) but not so far for Europe,
says: “We’re not afraid to be transparent. The difficulty is our
ability as a company to systematically capture that data across
multiple physicians and markets.”
Up till now, transparency has normally been a result of legal
actions rather than voluntarily introduced by companies or
doctors. Sunshine alone cannot in any case guarantee honesty.
But in the current climate of suspicion, pressure for greater
disclosure seems likely to grow.