Memorandum submitted by Jenny Hope Medical
Correspondent Daily Mail (PI 111)
In response to a request for written evidence
to the above inquiry, I submit the following observations. They
are my personal views, based on my experience as a medical journalist,
and do not represent the policy of the Daily Mail.
From a journalist's point of view it seems useful
to consider whether the influence exerted by the pharma industry
is overt, or covert, and how this affects news reporting. The
business of drug companies can do tremendous public good, drugs
save lives and improve the quality of lives, but they are extremely
powerful corporations which exist to make profit and recoup research
costs. The resulting conflict—making profit out of illness—does
not sit easily in the British context of free health provision.
Nevertheless, drug promotion is a necessary part of the contract.
This takes an all-pervasive form, ranging from sponsorship of
medical conferences to the use of PR companies to engage the lay
media in telling the public about their products. But it's an
overt influence that becomes part of the background noise of news
reporting. Anyone with knowledge of the healthcare industry, of
medicine and of the scientific community knows that many vested
interests reside among drug companies, device manufacturers, private
providers and insurers, researchers, universities and government
health spokespeople. Journalists are always looking for vested
interests and maintaining an awareness of hidden agenda.
For example, we may assume when a senior doctor
stands up on a platform at a drug launch there is a strong likelihood
he/she may have been paid a fee to be there. This will be taken
into account by journalists but won't necessarily undermine its
news value, negate or distort the coverage of the story. The enormous
halls of drug stands at international conferences quite clearly
signal the underlying promotional funding for a global industry.
Part of the business of these conferences is "selling"
stories to newspapers and broadcasters. The conduit is the PR
industry. PR companies organise the press conferences, arrange
the speakers and provide background material. There is a clear
agenda which experienced specialist reporters take into account.
The same considerations apply when press releases and company
information come into the offices of newspapers and broadcasting
organisations. We expect research data to be sourced and referenced,
and the format to follow the codes of practice devised by both
industries in the pursuit of ethical behaviour. But reporters
apply the same journalistic criteria to the information that we
would in covering any aspect of news, whether crime, transport,
education etc. However, staff reporters working for national news
organisations are not the only target for promotional activity.
When a story is in the public domain—or being placed with
the specific intention of generating publicity—someone will
write about it. If it's me than I know where the information is
coming from, the background, and carried out the interviews—there
is some quality control. When copy arrives from an agency or individual
freelance reporter it's unlikely to be exclusively supplied. They
make a living by supplying stories, often to as many outlets as
possible. This also raises the index of awareness about the information
provided.
Perhaps the most important issue in assessing
influence of the pharmaceutical industry on the NHS is whether
it corrupts the data used for an increasingly evidence-based service.
Doctors are no longer the prescribing "free agents"
they were 10 or 15 years ago. They are subject to NICE guidelines,
practice and hospital formularies, prescribing advisers from primary
care trusts which are putting increasing restrictions on the decisions
they make. The King's Fund, for example, in a recent report On
being A Doctor discussed growing constraints on the clinical freedom
of doctors, partly because of the tarnished reputation of the
profession in recent years. As a result, one could argue the focus
of attention must shift to the clinical trial and research data
used to gain approval of new drugs, not least a marketing licence,
and the post-marketing surveillance. Most medical research is
funded by drug company money. It is impossible for journalists
to assess whether data published in clinical journals or presented
at conferences—whatever the source—is corrupt. This
can happen in different ways; data omitted, misrepresentation
of findings, the skewed nature of the original protocol. On another
level, negative or inconclusive results rarely get published and
there appears to be no obligation to publish damaging results
from trials, even when NHS patients have taken part. A report
in The Lancet earlier this year found negative results from trials
on antidepressants in children had never been made public. Researchers
obtained information about unpublished trials from confidential
data held by the Committee on Safety of Medicines when they were
compiling NHS prescribing guidelines for doctors. Every request
for unpublished data from the pharmaceutical companies involved
met with a refusal.
As you know the Royal Society convened a working
group to look at how research reaches the lay media partly because,
in the words of the chairman Patrick Bateson, the results of scientific
research have profound effects on public opinion and policy. Journalists
have to rely on ethical committee procedures and peer review underpinning
publication in medical journals but even their editors express
disquiet about the process. Richard Horton, editor of The Lancet,
says in an article published in the New York Review of Books (2004
March 11:7-9) that "Journals have devolved into information-laundering
operations for the pharmaceutical industry." There is some
concern about the whole process of peer review used in journals;
the potential for bias, the old pals' act and plain wrongness
of interpretation of results. Who does it, what's their conflict
of interest? It may not be obviously pecuniary, it could be a
personality clash that's behind it. It's a vital part of how specialist
journalists assess the credibility of a story but it's a system
creaking under the strain of a myriad of vested interests. Ten
years ago Professor Peter Sleight, a leading cardiologist involved
in major heart disease trials, coined a memorable description.
"Peer review is 50% garbage, 50% malice and 10% good advice"
he told a Royal Society of Medicine meeting. "What can you
expect if a reviewer works in the same field and is almost certainly
a rival? Many actually steal data and hold up publication while
they publish it as their own research." Just a year later
I investigated a research fraud involving a faked trial in the
British Journal of Obstetrics and Gynaecology that led to a consultant
gynaecologist being struck off for life, the resignation of the
journal editor as president of the Royal College, and a shake-up
of the editorial board. However, I did not uncover the fraud by
unpicking the published research results—I discovered a
hospital inquiry was taking place in secret that led to the unravelling
of the scandal.
There has been an outcry over the secretive
workings of Government regulatory systems here and in the US.
The basic premise of the criticisms is that the MHRA and its advisory
committees appear to be in the pocket of the drug industry. As
a result, it is claimed, members and experts are too close to
the drug firms, which in many cases are their ex-employers, investigations
into safety are cursory and drug companies are allowed to choose
whichever data makes their product look safe. The scandals involving
SSRI products and Vioxx are topical examples. Since 1989 the cost
of licensing medicines has been covered almost entirely by fees
charged to the drug firms which may have fuelled public suspicion.
The shake-up of the CSM appears to be designed to address some
of these concerns, disallowing interests in the pharmaceutical
industry for example, which could be in place next year. But the
key point remains that documentation used by the MHRA to approve
licensing request is not available to the press. There is no way
of checking the documentation at present. The effect of opening
up the Freedom of Information Act in January is not yet known.
All data should be available for patients/ journalists/ doctors/
interested parties. It is a moot point whether summaries of clinical
trials in an online database will be sufficient. The devil is
in the detail. The commercial confidentiality caveat has to be
overcome. In the current climate, drug companies cannot be allowed
to continue to argue against openess on the basis of protecting
themselves commercially. All completed trials should be available
for independent scrutiny, whether they study licensed or unlicensed
uses. However, Europe-wide regulatory processes are taking precedence
over national systems in an increasingly global pharma economy.
It is unclear whether they will be in step with any changes recommended
or demanded in the UK.
How do the Press or public know when things
are going wrong? The most obvious signals are drug withdrawals,
Government safety warnings and research findings which give journalists
the opportunity to raise the alarm and investigate. There is a
contribution made to all of these processes by the yellow card
system for adverse reporting. Yet it's well recognised that relatively
few prescribers report adverse reactions and low levels of reporting
foster the assumption that little is wrong. I took part in consultation
carried out by the former deputy CMO Jeremy Metters to explore
different alternatives. The conclusion arrived at by journalists
(including the Guardian and BBC) is that unexpurgated information
from patients has to be accommodated and available for external
analysis. Patient reporting is no longer a privilege to be granted
to the public but a right. But post-marketing surveillance has
to be a more active process than waiting for damage sustained
by patients to be reported by them or their doctors. Patterns
of problems might emerge more quickly with a more intensive exercise.
What surveilliance is taking place of any planned surveillance
of drugs or devices- are these proposals submitted along with
applications for drug approvals? In France a new policy dealing
with drugs likely to be used on a large scale was brought in last
year. It requires pharmaceutical companies to organise a post-marketing
study of the public health impact of a drug, which includes close
follow up. According to a letter in the British Medical Journal
(BMJ 2004;329:1342) this policy has already resulted in an independent
large-scale study of 40,000 patients treated with new or traditional
anti-inflammatory drugs. More than 50 such studies have now been
agreed, which include in some circumstances a stepwise introduction
of a new drug. There may be overlap with NICE assessments but
the post-marketing elements may bear closer examination.
The same concerns apply to moves to reclassify
medicines from prescription to pharmacy only, which have Government
approval (following DoH working party). The system is equally
opaque. In the case of the first statin drug to be moved objections
were registered by the Consumer's Association and the Royal College
of General Practitioners on safety grounds. Individual doctors
also expressed concerns. These were published by my paper as part
of a story about the switch. However, there is no automatic access
to any submissions on such applications other than those released
direct to the Press and no access to documentation detailing the
reasons for the decision and opposition. The switch was approved
without any proper explanation—despite rejection for a similar
request made to the FDA two years ago—and the UK became
the first developed country in the world to take this step. Subsequently
there has been an explosion of advertising both of cholesterol
testing and the drug.
The pharma industry has taken an interest in
patient information and patient groups which has resulted in some
drug company funding of their activity. However, this should be
considered in the context of patients gaining their information
on prescription drugs from a product leaflet in which the format
and content are strictly controlled by legislation and usually
incomprehensible or frightening to the patient. Accusations of
disease-mongering are not entirely disinterested. They reveal
tensions between prescribing doctors and public health specialists
who want population-wide strategies to make a difference, and
part of that is managing medical risk factors ranging from osteoporosis
to high blood pressure. Guidelines are increasingly being set
by professional bodies which define the limits of potential intervention.
Raised blood pressure is a serious health threat, I might expect
an affected individual to think about it seven times a day—at
least until it's under control. Many people, once they have been
told they are at risk, or have been diagnosed with a medical condition,
crave more information. They get it from a variety of sources,
friends, newspapers, patient groups, the Internet—there
are more than 20,000 health-related Internet sites. Surveys consistently
show that newly diagnosed patients are disappointed with the level
of information available to them about their condition. MORI research
shows the most preferred method of communication of patient information
is leaflets from the GP surgery. A recent study found the UK performed
worse than other major Commonwealth countries and the US on patients
having information about medicines including side effects. If
we accept there is a consensus that people need more information
to make choices about their health—even if they are the
wrong choices—then disease awareness campaigns can play
a useful role. There are an estimated one million undiagnosed
diabetics in Britain, and this is a condition which can cause
organ damage and premature death. We know companies manufacturing
drugs in this area have a commercial interest in promoting awareness,
but there is also a public interest that results in energetic
activity on the part of patient groups. Donations are made to
patient groups by drug companies but in my experience charities
tend to ringfence this money for "educational" projects
such as leaflets where the funding source is clearly stated, specific
drugs not mentioned and an arms-length policy adopted. Harry Cayton,
when he was executive director of the Alzheimer's Society, said
it was a caricature to say that patient groups were "fluffy
bunnies" at the mercy of the "ravening wolves"
of the drug industry. The Society had strict guidelines for its
relationship and acceptance of donations, and he acknowledged
the need for patient groups to have a good relationship with the
industry not least to fill the information gap left by the NHS.
Any restrictions or banning of such a relationship which involved
the removal of pharma funding would surely have to be replaced
by state-funded grants.
One further point about the influence of the
industry. Quite apart from the growing significance of PFI in
capital investment, we're looking at an NHS where there will be
greater involvement of the public sector in the near future. An
estimated 15% of elective surgery on NHS patients will be carried
out privately but with NHS funding by 2008—so the profit
motive will be more in evidence. It's not just in acute care that
the scene is shifting. US-managed care of chronic conditions has
already arrived in pilot form, and there is another NHS pilot
scheme being run in a north London PCT which is managed by a wholly
owned subsidiary of a major drug company and provides "care
management tools". The PCT states that it does not endorse
the use of the company's drugs or encourage any additional access
by drug company reps. The NHS Improvement Plan itself actually
makes reference to working with pharmaceutical companies. It states
that "pharmaceutical industry involvement in the development
and implementation of national service frameworks would benefit
both the NHS and industry." It also calls for "faster
and more effective recruitment of patients into clinical trials
via the NHS enabling new medicines to be brought on stream more
quickly". We probably need to see a more transparent account
of the pros and cons of private involvement in the NHS where profits
are being made in the provision of healthcare, and more independent
analysis. Whether it's PFI, acute care or chronic disease management.
It's not just in the regulatory processes that we need more scrutiny,
much though these are in need of reform.
|
