BMJ 2002;324:320 ( 2 February )
Katherine Burke London
Drug companies have successfully withheld important data from investigations carried out by the National Institute for Clinical Excellence (NICE) because the institute has no powers of inspection, the parliamentary health committee inquiry heard last week.
The institute’s chief executive, Andrew Dillon, told MPs that drug companies have refused to disclose the patient-level data needed to calculate how cost effective interferon beta is for treating multiple sclerosis.
"Their reasons were that it was confidential information that would breach the agreement they had with these patients and that it wasn’t relevant," said Mr Dillon during the third hearing of the committee’s inquiry into NICE.
Two experts—Sheila Bird, a Cambridge biostatistician and a member of the institute’s appraisal committee, and Iain Chalmers, director of the Cochrane Centre—have both written to the select committee expressing their concern that drug companies are failing to grant the institute full access to research records.
Dr Bird suggested that NICE could produce more accurate estimates of cost effectiveness if it was partially covered by the Medicines Act to allow appraisers access to companies’ post-licence trials data.
Gauging the efficacy of a drug is fraught with problems, according to the Cochrane Centre, because negative results are rarely published in medical journals. In his submission to the inquiry Dr Chalmers said: "Important data have been withheld from NICE by companies whose interests would not be served by that."
One solution might be to make all researchers register their randomised control trials before they begin, the Cochrane Centre says, so that systematic reviewers could then try to find reports of the trials.
Mr Dillon told the inquiry that he would like NICE to have parallel powers to the Medicines Control Agency, which can inspect company premises. Until then, he said, his hands are tied because he does not have the name of the company alleged to have withheld information and the details of the data withheld.
"If I’m presented with the information then I will seek the information from the company—I can’t just randomly approach companies," he said.
Senior figures at NICE seemed ruffled last week as they rebutted claims that their guidance was often late, riddled with mistakes, and sometimes contradicted the manufacturers’ own information. Conservative MP David Amess accused the three senior witnesses from the institute of complacency, self congratulation, and being "pretty pleased with yourselves."
Professor Michael Rawlins, chairman of NICE, strongly rebutted the criticisms. "If we have done something to eradicate [postcode prescribing] I do feel quite proud, and as time goes on we will also make sure there’s access to treatments but also the quality of care for patients is improved," he said. "We do not believe our guidance is flawed. It’s constructed to a very robust process, probably more robust and open and transparent than any other organisation I’ve been involved in," said Professor Rawlins, who has worked at the Medicines Control Agency and the European Agency for the Evaluation of Medicinal Products.
Professor Rawlins explained that the institute can judge only cost effectiveness—in terms of quality of life years; it cannot determine whether there is enough money to give that drug to all the patients who need it.
"NICE can’t commit half a million from the treasury. It becomes an issue for government. We would go as far as clinical cost effectiveness but [the government] has to do the affordability," he said.
Professor Rawlins added that NICE would like to get more input from health authorities and clinicians about which interventions and disease areas require appraisal or guidance. Surgical procedures such as total hip replacements could be benchmarked, so that clinicians can compare how much the joint improves the patient’s quality of life against how easy it is to fit and how long it lasts.
NICE is to create a citizen's council, modelled on those used by the King’s Fund, to make ethical decisions. The jury will meet for several days and produce a report on such issues as if and how quality of life years should be modified to make them fairer to older people.