Drug regulator criticised for error in reporting consultation results
http://www.100md.com
《英国医生杂志》
The UK consumers' association Which? has called for a review of the Medicines and Healthcare Products Regulatory Agency (MHRA) after the organisation admitted that it had made an "administrative error" in reporting results of a public consultation on the availability of the over the counter statin Zocor Heart-Pro (simvastatin).
The agency held a public consultation last year on whether the cholesterol lowering drug should be available from pharmacies without a prescription. A report by the Committee on Safety of Medicines was made available for consultation and 100 pharmaceutical groups; medical colleges; and organisations, patient groups, industry representatives, and members of the public replied. In May 2004, the MHRA reported on its website that "about two thirds of respondents were in favour of the proposal" and one statin, Zocor Heart-Pro, became available without a prescription in July 2004.
The Drug and Therapeutics Bulletin, a journal published by Which?, did its own analysis of the consultation responses, based on 80 of the 100 responses that were available from the MHRA on request. The remaining 20 did not wish their responses to be made publicly available. The analysis by the journal showed that only a third were in favour of the proposal, a third were against, and a third expressed views that were neither for nor against.
Ike Iheanacho, editor of the bulletin, said, "We calculated that even if the 20 responses we had not seen had been in favour of the proposal, only 45% of the responses could potentially have been in favour of the change—not the two thirds reported by the MHRA."
The bulletin contacted the agency with its findings before the final decision to make statins available without a prescription was announced, but the agency refused to accept its findings. However, after a letter was sent to Kent Woods, the agency's chief executive, the regulator said last week that it had made an "administrative error" and would make the full text of responses to consultations available on its website.
In a statement, the agency said, "We recently reported consultation findings on our website which were incorrect, due to an administrative error. To clarify, we reported that in responding to a consultation exercise concerning the change of Zocor Heart-Pro (10 mg tablets) from a prescription only medicine (POM) to pharmacy status, two thirds of respondents were in favour of the switch. In fact a third were in favour, a third against and the reminder were not opposed but raised issues to be considered."
The statement continued, "We in no way intended to misrepresent the results and can assure the public and other interested parties that the correct findings were given to the Committee on Safety of Medicines, who made their recommendations with the full facts in front of them. We have today published a listing of all the consultation responses on our website, together with the full text of all responses other than those where the respondent has not given consent for public disclosure. We are now adopting this model for all future switch consultations, so as to avoid any further confusion."(Drug Susan Mayor)
The agency held a public consultation last year on whether the cholesterol lowering drug should be available from pharmacies without a prescription. A report by the Committee on Safety of Medicines was made available for consultation and 100 pharmaceutical groups; medical colleges; and organisations, patient groups, industry representatives, and members of the public replied. In May 2004, the MHRA reported on its website that "about two thirds of respondents were in favour of the proposal" and one statin, Zocor Heart-Pro, became available without a prescription in July 2004.
The Drug and Therapeutics Bulletin, a journal published by Which?, did its own analysis of the consultation responses, based on 80 of the 100 responses that were available from the MHRA on request. The remaining 20 did not wish their responses to be made publicly available. The analysis by the journal showed that only a third were in favour of the proposal, a third were against, and a third expressed views that were neither for nor against.
Ike Iheanacho, editor of the bulletin, said, "We calculated that even if the 20 responses we had not seen had been in favour of the proposal, only 45% of the responses could potentially have been in favour of the change—not the two thirds reported by the MHRA."
The bulletin contacted the agency with its findings before the final decision to make statins available without a prescription was announced, but the agency refused to accept its findings. However, after a letter was sent to Kent Woods, the agency's chief executive, the regulator said last week that it had made an "administrative error" and would make the full text of responses to consultations available on its website.
In a statement, the agency said, "We recently reported consultation findings on our website which were incorrect, due to an administrative error. To clarify, we reported that in responding to a consultation exercise concerning the change of Zocor Heart-Pro (10 mg tablets) from a prescription only medicine (POM) to pharmacy status, two thirds of respondents were in favour of the switch. In fact a third were in favour, a third against and the reminder were not opposed but raised issues to be considered."
The statement continued, "We in no way intended to misrepresent the results and can assure the public and other interested parties that the correct findings were given to the Committee on Safety of Medicines, who made their recommendations with the full facts in front of them. We have today published a listing of all the consultation responses on our website, together with the full text of all responses other than those where the respondent has not given consent for public disclosure. We are now adopting this model for all future switch consultations, so as to avoid any further confusion."(Drug Susan Mayor)