Monday, November 17, 2008

UK Parliament blames MHRA and prescribers

In march 2005 the review "The Influence of Pharmaceutical Industry" was concluded. It's amazing that it raises so many problems such as MHRA failure in all regulatory process and the accountability prescribers should hold dear.
These are some excerpts and there's much more on the review:

"The industry is by no means solely to blame for the difficulties we describe. The regulators and prescribers are also open to criticism. The regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has failed to adequately scrutinise licensing data and its post-marketing surveillance is inadequate.The MHRA Chairman stated that trust was integral to effective regulation, but trust, while convenient, may mean that the regulatory process is not strict enough.The organisation has been too close to the industry, a closeness underpinned by common policy objectives, agreed processes, frequent contact, consultation and interchange of staff. We are concerned that a rather lax regime is exacerbated by the MHRA’s need to compete with other European regulators for licence application business.

Inappropriate prescription of medicines by GPs is of particular concern. Some have prescribed SSRIs, for instance, on a grand scale.This is in part due to inadequacies in the education of medical practitioners which has meant that too few non-specialists are able to make objective assessments of the merits of drugs and too many seem not to recognise how little is known about the properties of a drug at the time of licensing, particularly about its adverse consequences. However, many prescribers have behaved responsibly and with restraint, which makes those who have not, all the more culpable.The constraints in place for hospital doctors do not apply to GPs. Drug companies are criticised for giving hospitality and recruiting ‘key opinion leaders’, but the prescribers must be equally to blame for accepting the hospitality and some ‘key opinion leaders’ for lending their names to work they did not produce, often for very considerable sums.

Greater transparency is also fundamental to the medicines regulatory system.There has to be better public access to materials considered by the MHRA prior to licensing.

The aim of new drugs should be real therapeutic benefit for patients. Clinical trials should focus on using health outcomes that are relevant to patients.To achieve this we recommend better communication between the MHRA and companies early in the early stages of the development of a drug. Improvements in the post-licensing surveillance of medicines are also badly needed. This will require systematic appraisals of medicines.

We recommend that more research be undertaken into the adverse effects of drugs, both during drug development and medicines licensing. The Government should, as a matter of urgency, fund research into the costs of drug-induced illness. (emphasis mine)

We recommend that the MHRA find ways of ensuring greater restraint in medicines promotion, particularly soon after launch. There should also be strengthened guidelines requiring the declaration of links between pharmaceutical companies and patient groups. In view of the failings of the MHRA, we recommend a fundamental review of the organisation in order to ensure that safe and effective medicines,with necessary prescribing constraints, are licensed.
In view of the failings of the MHRA, we recommend a fundamental review of the organisation in order to ensure that safe and effective medicines, with necessary prescribing constraints, are licensed." p. 4-5

Problems and solutions are known but nothing is done. Blaming MHRA and prescribers is not enough. After publishing this review UK Parliament has forgotten health problems even the costs of drug-induced illness.


Fiddy said...

Youv'e been tagged.

Please read:



Ana said...

1) I fear the MHRA and UK Parliament retaliation.


Radagast said...


This report has been quietly mothballed, and the MHRA refuses to comment on it, saying that it's the Department of Health has already commented. The D'oh refused to comment further, when I asked it.

To my knowledge, excepting direct patient feedback (the yellow card scheme), none of the recommendations has been implemented.


Ana said...

I've just posted to remember that they know it all.
The review raises many issues including the drug-induced suicide ideation of SSRIs that has nothing to do with the disease.
I'll post more from this review.
I guess I've downloaded a .pdf of a yellow card.
If I remember correctly there were so many items to fill that I believe many people give up reporting.