BMJ  2006;333:1087 (25 November), doi:10.1136/bmj.39041.354074.DB

News

Experts defend NICE against attack by US politician

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."

This article has been cited by other articles:

• Maynard, A. (2007). Transparency in health technology assessments. BMJ 334: 594-595 [Full text]  

Rapid Responses:

Read all Rapid Responses

Mr. Azar, NICE acts on more robust evidence.

Anton E Joseph
bmj.com, 9 Dec 2006 [Full text]