[e-drug] Attacks on British and German Drug Therapy Institutes

[e-drug@healthnet.org]

E-DRUG: Attacks on British and German Drug Review Institutes
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[Attacks on the British National Institute for Health and Clinical
Excellence (NICE) and the German Institute for Quality and Economic
Efficiency in Health Care in Cologne were reported in the BMJ this week.
After the attacks on the Australian PBS last year, this is an indication of
growing drug companies frustration with such institutes, which influence
prescribers in rich markets. Big pharma seems to get lobbying assistance
from the USA government. Copied as fair use; WB]


http://www.bmj.com/cgi/content/full/333/7578/1087
BMJ  2006;333:1087 (25 November), doi:10.1136/bmj.39041.354074.DB 
News
Experts defend NICE against attack by US politician 
Zosia Kmietowicz 
1 London 

Commentators have defended the work of the National Institute for Health and
Clinical Excellence (NICE) after a newspaper claimed that the White House
was backing large drug companies in their efforts to have unrestricted
access to the NHS as part of a free market. 

The US deputy secretary for health, Alex Azar, who met officials in London
last week, said that mechanisms such those of NICE for rationing drugs to
keep costs down stifle innovation, the article in the Guardian reported (14
Nov, p 1). Allowing all new drugs to be used in the NHS would result in drug
companies "fighting it out" on price, he said, which would cut drug costs. 

The drug companies have themselves repeatedly lobbied ministers for NICE to
be reformed and to allow their drugs to be made available on the NHS more
quickly. 

In his interview with the Guardian Mr Azar said he recognised that
healthcare costs in all rich nations were rising while budgets were
shrinking as the population aged. "On the other side we have to focus on
long-term innovation," he said in the article. 

"How are we making sure that we don't take steps on cost containment that
are short-sighted and prevent the investment in long-term biomedical
research and development and innovation, so that when my kids are senior
citizens we have the next generation and next, next, next generation of
drugs?" 

Charles Medawar, director of Social Audit, an independent health consumer
lobby group, described the attack on NICE as "absolutely typical behaviour
for the United States." 

"It is extremely disruptive," he said. "The whole emphasis behind this
initiative [NICE] is that new drugs are in themselves welcome, but there
needs to be an effort to distinguish between them on grounds of
effectiveness." 

Chris Ham, professor of heath policy and management at the University of
Birmingham, said he was not surprised by pressure from the US. "It is
entirely to be expected. A lot of pharmaceutical companies have been
frustrated at what they see as delays and barriers to getting their drugs
approved for use on the NHS," he said. "One hopes that the UK government
will be robust in its response." 

Ike Iheanacho, editor of the Drug and Therapeutics Bulletin, said that Mr
Azar's suggestion that NICE stifles innovation in the drug industry is "at
best questionable and at worst laughable." 

He said, "A lot of the arguments are that if drug companies were to get
unfettered access to the NHS and to patients that would drive down the drugs
bill. If it was so simple, why has this not happened before? NICE has only
been in existence for six years, and before then we had spiralling drug
costs." 

Dr Iheanacho also challenged the use of the word "innovation" in relation to
the development of new pharmaceutical compounds. Many new drugs are just
that, he said: new but not necessarily innovative. 

"The kind of activity that consumes a lot of drug companies' time and effort
is making minor modifications to drugs that are coming off patent, and it is
questionable whether these new products really offer any compelling
advantages to patients," he said. 

"Whether one agrees or disagrees with individual decisions that NICE makes,
most commentators agree that a system is needed to decide which drugs should
be available on the NHS, and to get rid of it would be a retrograde step." 

The Guardian article quoted Mr Azar as saying that he had "some great
discussions" with Patricia Hewitt, the health secretary for England, when
she visited the US two weeks ago. He also said he supported direct
advertising of drugs to patients, something permitted in the US but banned
throughout Europe. 

A spokesman for the US Department of Health and Human Services said the
purpose of Mr Azar's trip was to share experiences of the US health service
and not to try to influence politicians to change national policies. 

In a letter to the Guardian in response to the article Andrew Hotchkiss,
chairman of the American Pharmaceutical Group (APG), wrote, "The APG alone
invests £1.5bn [2.2bn; $2.8bn] in the UK every year in our quest to find new
medicines for often under-served diseases such as Alzheimer's and
mental-health conditions" (17 Nov, p 41). 

He added, "We understand the need for a body in a publicly funded system
where priorities must be set, but our concerns lie with the transparency and
fairness of the NICE process and the delay it causes patients in gaining
access to new medicines, even when proven to be clinically and
cost-effective." 

Meanwhile the health minister Andy Burnham wrote in the same issue (17 Nov,
p 41): "There is no question of anyone bypassing the clear processes which
are used to evaluate new drugs for use in the NHS. The National Institute
for Clinical Excellence is an independent body, established to make
decisions on the clinical and cost-effectiveness of products based on the
latest evidence. 

"Sometimes NICE has to say no to a treatment because the evidence does not
support it as being clinically and cost-effective. These are not easy
recommendations for anybody to make and we recognise that when this happens
there are implications for patients and their carers*not just drugs
companies. But it is the fairest way in an environment where resources are
limited." 

---


http://www.bmj.com/cgi/content/full/333/7578/1087-a 
BMJ  2006;333:1087 (25 November), doi:10.1136/bmj.39042.547674.94 
News
Germany's drug regulatory body is attacked 
Annette Tuffs 
1 Heidelberg 

The independent institute that assesses new drugs in Germany is facing
criticisms similar to those aimed at its equivalent body in the United
Kingdom, the National Institute for Health and Clinical Excellence. 

Last week in Cologne a member of an association for people with diabetes and
representatives of the drug industry walked out of a hearing of the
Institute for Quality and Economic Efficiency in Health Care in Cologne
because they were not allowed to record the hearing, which was on the use of
short acting insulin analogues. 

The institute has provoked anger among patients' groups and the drug
industry by saying that no evidence has been shown that short acting insulin
analogues had any advantage over human insulin (BMJ 2006;332:874). 

After the walk-out drug firms accused the institute, which was founded in
2004, of insufficient transparency. The institute's director, Peter Sawicki,
said that its rules did not allow participants to record hearings and that
this had always been the case. 

Tension between the drug industry and the institute has grown since the
German government proposed expanding the institute's role, so that it will
no longer consider only the clinical effectiveness of new drugs but also
their cost effectiveness. The proposal is part of the government's package
of reforms currently before parliament (BMJ 2006;333:720, 7 Oct). 

The institute's evidence based evaluations will become the basis for
decisions by the federal joint committee of doctors, health insurance
companies, and patients' representatives that decides which treatments will
be reimbursed by the state health insurance companies. Under the new reforms
this committee will include independent members as well as representatives
of doctors and health insurance companies chosen by the health ministry. 

"For the analysis of the cost effectiveness of treatments we will use
internationally accepted methods, just as we do for looking at the
scientific evidence," said Professor Sawicki. 

Before his institute can carry out any analysis, however, the government
will have to decide what costs are to be taken into account when weighing up
a drug's cost effectiveness*whether it is the costs to the health insurance
companies, the health system, or the social security systems. 

Dr Sawicki said that a public debate is needed involving the federal ethics
committee and other institutions to consider the use of monetary equivalents
of measures of clinical effectiveness such as survival and number of quality
adjusted life years. 

The institute's work is also under pressure because of difficulties in
recruiting experts. Each project is advertised on the institute's homepage
(www.iqwig.de), and renowned experts are also directly asked to apply.
"However, experts have to be familiar with the methods of evidence based
medicine, and this is not so common in Germany," said Professor Sawicki.
They also have to be expert on the particular treatment. They have to spend
a considerable amount of time on the preparation of a report, on average 100
(paid) working days. 

"Another new problem is pressure from peers, which recently has forced one
expert to withdraw for career reasons," said Professor Sawicki. Besides
recruiting experts from abroad, he hopes to solve the problem by setting up
small independent centres, with the help of government funding, in German
university hospitals that have expertise in evidence based medicine.