British Shake-up for drug licensing body
Thu, 11 Nov 2004
“The damage done by the public believing they have been lied to or defrauded is difficult to repair.”
A shake up is taking place in the UK as the culture of secrecy and the pharmaceutical industry’s influence on the Medicines and Healthcare Regulatory Authority (MHRA, equivalent to the FDA) will give way to greater transparency and public involvement into the drug regulatory process. BBC reports (below) that a new code of conduct has been drawn up to ensure independence from industry’s influence:
“Two lay representatives will sit on the CSM, the new name for the Committee for the Safety of Medicines, as well as patient representatives on every expert advisory group under the plans.”
These changes are a result of public pressure following the BBC-Panorama series in which it was revealed how intertwined the pharmaceutical industry was with the regulatory agency. The MHRA was more concerned with protecting GlaxoSmithKline than the public interest – even when it was revealed that GSK concealed evidence of drug-induced Paxil / Seroxat suicides, violence and severe withdrawal symptoms.
Like the MHRA, the FDA had failed to act in the public interest, failed to analyze severe adverse events – such as suicidal behavior linked to SSRI antidepressants and neurontin, heart attacks linked to Vioxx– until pressure was brought to bear. The FDA did not analyze the SSRI data from pediatric trial until testimonies of grieving families whose children attempted or committed suicide soon after taking an SSRI antidepressant raised a public furor.
Note the contrast between British regulators who are moving in the right direction and opening up the secretive club that binds drug industry representatives and regulators the FDA continues to resist meaningful change to improve the safety standards of the drug approval process.
Dr. Steven Galson, director of FDA’s Center for Drug Evaluation and Research said he saw no need for a thorough overhaul of the agency’s culture or systems.
“We are very proud of our independence, and we think most of the charges being leveled are just not accurate,” he said. “We hope this won’t result in important products for the public health of the United States being delayed in their marketing.” [NYT F.D.A.’s Drug Safety System Will Get Outside Review, By GARDINER HARRIS, November 6, 2004 http://www.nytimes.com/2004/11/06/politics/06fda.html ]
An assessment of FDA’s conduct by a committee of the Institute of Medicine (IOM) – as was announced by the FDA–is nothing more than an effort to deflect criticism by dodging behind another layer of like-minded panels. IOM advisory committees are just as removed from the public interest, and just as riddled with conflicts of interest as are FDA advisory committees. An IOM committee approved human pesticide experiments in violation of every code of research ethics.
Contact: Vera Hassner Sharav
212-595-8974
Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/1/hi/health/4002185.stm
Shake-up for drug licensing body
November 11, 2004
A reform of the way drugs are regulated has been outlined by ministers to make the system more independent.
A new code of conduct has been drawn up for the Medicines and Healthcare products Regulatory Authority (MHRA) body responsible for licensing.
It proposes not allowing the members of the body, the Commission for the Safety of Medicines (CSM), to hold interests in the pharmaceutical industry.
It also calls for more patient involvement in the process.
Two lay representatives will sit on the CSM, the new name for the Committee for the Safety of Medicines, as well as patient representatives on every expert advisory group under the plans.
The MHRA has also written to pharmaceutical companies to demand more action on their agreement to publish their clinical trial data.
‘Secrecy’
The move comes after heavy criticism at the way the MHRA operates.
On Wednesday in a Westminster Hall debate Dr Ian Gibson, chairman of the Commons science and technology select committee, said the MHRA had an image problem.
He said it was “gaining a reputation for not giving out information”.
“I think it is time the culture of secrecy was addressed.
“The damage done by the public believing they have been lied to or defrauded is difficult to repair.
“It is the only regulatory agency that is fully industry funded.
“It is a difficult task to convince people that a regulatory body entirely funded by the industry is impartial.”
Last month BBC’s Panorama programme criticised the MHRA over its handling of anti-depressant drug Seroxat.
The Panorama investigation claimed vital information relating to Seroxat was overlooked.
Impartial
It suggested the drug could be addictive and increase suicidal feelings in young adults.
Health Minister Lord Warner said it was important the MHRA was “open and transparent”.
He said the changes meant that “everyone can be confident in the impartial and independent expert advice given on the safety of medicines”.
Professor Sir Alasdair Breckenridge said: “Proposals for the new commission incorporating strengthening of patient and lay involvement, tightening of the rules of interest and increased transparency will move the MHRA forward in its aims of improving public health.”
And Harry Cayton, the government’s patients tzar, welcomed the increased involvement of patients, saying it would increase the agency’s “expertise and strengthen its ability to take account of the public interest”.
“I hope that following these reforms the MHRA will be more active in communicating with the public about its processes and decisions.”
Published: 2004/11/11 10:57:48 GMT
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