Memorandum by Insulin Dependent Diabetes
Trust (PI 30)
INTRODUCTION
The Insulin Dependent Diabetes Trust is a registered
charity offering information and support to people with diabetes
and their families. The Trust formed in 1994 as a direct result
of the adverse effects experienced by a significant number of
people to synthetic insulin made by genetic modification, introduced
in 1982.
Synthetic GM "human" insulin was introduced
into the market without long-term safety data and as shown in
the Cochrane Review,[115]114
without scientific proof of advantage over existing purified animal
insulins with their long history of safety and efficacy. Nevertheless,
the significantly more expensive synthetic GM insulin became first
line treatment for insulin requiring diabetes and the adverse
effects experienced by at least 10% of patients (30,000) have
been largely ignored or disputed by both the medical profession
and the regulatory authorities.
The vast majority of patients have not, and
are not, given the treatment choice of animal or synthetic GM
insulin which should be theirs by right and nor have they been
provided with information about the risks and benefits of all
insulin types so that their choice is informed.
It is difficult to find an explanation for this
situation which may have an effect on the health of patients,
on their ability to have an informed choice of treatment and on
the overall cost of diabetes to the NHS. We believe that in part
the explanation must be due to the influence of the pharmaceutical
industry.
In their conclusion, the Cochrane reviewers114
expressed concerns that the story of the introduction of synthetic
GM "human" insulin might be repeated by contemporary
launching campaigns to introduce pharmaceutical and technological
innovations that are not backed up by sufficient proof of their
advantages and safety. It is for this reason that the Inquiry
may wish to consider this "story" as an example of the
influence of the pharmaceutical industry over health outcomes
and health policies.
THE CONDUCT
OF MEDICAL
RESEARCH
We are concerned about the quality of industry
sponsored research. The Cochrane Review of animal and synthetic
GM "human" insulin showed no evidence of benefit and
a lack of research to compare mortality and diabetic complication
rates which are very important issues for people with diabetes
wishing to make treatment choices. However, it also showed that
the research that was carried out was "methodologically poor".
Yet despite this poor quality research, lack of evidence of benefit
and no long-term safety data, synthetic "human" insulin
became first line treatment with over 84% of patients transferred
to it, too often for no clinical reason.
Our concerns were compounded in 2004, when a
further Cochrane Review[116]115
comparing the more recently developed insulin analogues with synthetic
"human" insulin, also showed that the research was "methodologically
poor". As many as 81% of the studies were sponsored by the
analogue insulin manufacturers themselves and the remaining studies
had no sponsor stated. Insulin analogues are now taking over as
first line treatment so no lessons have been learnt.
From this we have concluded that the quality
of industry research has not improved and nor have the demands
of the regulatory authorities become more vigilant in requiring
better quality research.
From our experience, we have to raise the following
points:
(a) the quality of studies carried out by
the pharmaceutical companies wishing to market and promote a new
drug;
(b) the lack of independent studies to inform
decision making and the bias that may be introduced, especially
publication bias that is likely to occur if the majority of the
studies are carried out by industry who are unlikely to publish
negative studies;
(c) the quality and efficiency of the marketing
approval process whereby drugs are approved for use on the basis
of largely poor quality research;
(d) the post marketing surveillance system
which does not appear to require evidence from research carried
out independently of the pharmaceutical industry; and
(e) in view of the lack of evidence of benefit
of synthetic GM insulins, it is surprising that NICE has never
evaluated insulin prescribing, assessed cost effectiveness and
issued guidelines on insulin prescribing.
Our concerns are summarised by Edwin Gale, Professor
of Diabetic Medicine in Bristol,[117]116
writing about the marketing of troglitazone, a Type 2 diabetes
drug which had to be withdrawn for safety reasons six weeks after
gaining marketing approval in the UK:
"Big pharmaceutical companies see clinical
studies as a means of satisfying the regulators and promoting
sales, not of providing information. Published reports are not
designed to help clinicians persuade us to use the new agent effectively:
they are selected and slanted in such a way as to persuade us
to use the new agent. Hence the huge amount of junk literature
of irrelevant and badly reported studies with misleadingly optimistic
titles. No one will ever know how many people it (troglitazone)
killed, perhaps between 200-1,000, yet the culture of secrecy
protected the industry from full and timely disclosures of the
mounting evidence of risk."
THE PROVISION
OF DRUG
INFORMATION AND
PROMOTION
1. Advertising and promotion
While direct to consumer advertising of drugs
(DTCA) is not allowed in the UK, we are concerned at the subtle
ways in which industry circumvents this situation to reach the
general public. We cite the following examples:
— Using the press and celebrities to
indirectly advertise. For example, the press covered TV chef Anthony
Worall Thompson cooking for the staff of Novo Nordisk to launch
their new analogue insulin Levermir.[118]117
— Industry sponsorship of medical charities
occurs frequently and while the agreement may be for sponsorship
and not endorsement of their products, the perception of the charities'
membership may well be different and the products seen as acceptable
and even preferable by the charity associating itself with the
company. Examples include an advertisement in Readers Digest May
2002 Diabetes UK supported by Novo Nordisk and the Sexual Dysfunction
Association advertising in the March/April edition of consumer
magazine, Balance has with Pfizer prominently on an advertisement.
— The direct marketing to patients
of insulin injection devices that can only be used with a particular
company's insulin brand indirectly advertises and promotes the
use of that particular insulin. (Complaint referred to and upheld
by the ABPI complaints body)
2. Influencing and advertising to physicians
We are concerned at the close links between
industry and the medical profession. After failing to obtain recognition
of the adverse effects to synthetic GM insulin, some patients
attempted legal action against the manufacturer Novo and attracted
media attention as a result of sudden unexplained deaths. Novo
employed a public relations company to defend the safety profile
of genetically modified human insulin. They recommended a reactive
strategy of a issues/crisis management programme that spanned
three years and involved media training of company headquarters
staff and UK medical spokespeople. The litigation collapsed and
the PR company's description of the results was that Novo's reputation
remaining intact among patients, health professionals and media,
that sales continued to grow and the medical professionals accepted
that human insulin has an excellent safety profile. While such
action may have been in the best interests of the company and
the promotion of their insulin, it has to be noted that the insulin
could not be defended on the grounds of scientific evidence. It
also demonstrates that there was unacceptable influence used to
influence the medical profession and patients in favour their
product.
To further quote Professor Edwin Gale[119]118
on the issue of troglitazone, but which could equally apply to
synthetic GM insulins: "Not one physician stood up to say
that the evidence base was inadequate and that no drug for diabetes
is worth dying for . . . Our profession did nothing to protect
the public. No one wants to remember troglitazone. It is treated
as an unfortunate aberration of the system. It was not. It was
a consequence of the system. Finding that out certainly changed
my life."
3. Selective advertising
Industry stops advertising the drugs they no
longer wish to promote in favour new more expensive drugs. While
this is understandable from the company's perspective, it adversely
affects patients being given an informed choice of treatment or
alternatives if they experience adverse effects from the new product.
For example animal insulins have not been advertised to physicians
for many years and there is a perception amongst physicians and
healthcare professionals that they are no longer available as
a result of which they misinform patients.
4. Pharmaceutical company promotional materials
Promotional materials to medical and nursing
staff affect prescribing habits. A survey[120]119
examining the influences on 227 diabetes specialist nurses showed
that regardless of their lack of legal status to prescribe and
patients' right to a an informed choice of treatment, 96% felt
that they predominantly chose the insulin type. While this choice
was primarily influenced by their personal experience of a given
insulin type, the second influence was literature and pharmaceutical
promotion of a particular insulin type and notably not scientific
evidence of benefit.
5. Local pharmaceutical contracts
In some areas drug prescribing is influenced
by prescriptive protocols and local pharmaceutical contracts for
the exclusive use of a particular insulin brand. While this may
reduce overall costs, it removes the right of choice from both
patients and doctors.
6. The provision of drug information can be
incomplete
We are concerned that in the UK patients and
physicians are not provided with full information about risks
and benefits and that this must in part be due to the actions
of both industry and the regulatory authority in the UK.
Patients and physicians involved in diabetes
care receive restricted information compared to the United States.
For example: Journals in the US make reference
to the potential carcinogenic effects of insulin analogues in
advertisements to both patients and professionals patients[121]120
but in the UK published journals have less information and do
not include the potential for carcinogenic effects.[122]121,
[123]122
The result is that treatment choices of both physicians and patients
are not fully informed and there could be long-term health damage.
The lack of this information cannot be explained as a matter of
commercially sensitive information as all insulin analogues have
this potential.
PROFESSIONAL AND
PATIENT EDUCATION
We do not believe that pharmaceutical companies
should be involved in patient or professional education as they
have a vested interest in promoting their own products or company
name. In our experience, industry's record to date in the provision
of the required high quality evidence to inform treatment decisions
leaves much to be desired as has been demonstrated by the issues
raised throughout this document.
If industry wish to be magnanimous and support
patient education programmes, then a system should be devised
whereby they can donate to a central fund that then allocates
funding to specific education programmes not necessarily in a
specific company's particular section of the market.
115 Cochrane Collaboration Database, 2002. "Human"
insulin versus animal insulin in people with diabetes mellitus. Back
116
Cochrane Database 2004. Short acting insulin analogues versus
regular human insulin in patients with diabetes mellitus. Back
117
Professor Edwin Gale. Diabetes Digest; Vol 2 Number 4, 2003. Back
118
Crawley Observer. 30.6.04 Top chef cooks at town firm. Back
119
Professor Edwin Gale. Diabetes Digest; Vol 2 Number 4, 2003. Back
120
Practical Diabetes International; Sept 2003 Vol 20 No 7. Back
121
Diabetes Health, June 2004. Back
122
Practical Diabetes, July/August 2004. Back
123
Diabetic Medicine, July 2004. Back
| 
