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The Medicines and Healthcare products Regulatory Agency (MHRA) (an executive agency of the Department of Health) states that

“We enhance and safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe.”

They have just utterly betrayed the important job with which they are charged, “ensuring that medicines . . . work”, by allowing homeopathic products to be labelled with indications without requiring any evidence that the claims are true (they aren’t).

The MHRA chief executive, Professor Kent Woods, should be fired immediately for dereliction of the duty of the MHRA to protect the public from medicines that don’t work.

The MHRA was founded in 2003 by merging the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). The MCA was created by the UK Medicines Act 1968, in the wake of the thalidomide disaster.

he MHRA have, incredibly, made it legal to advertise things like this gem from Nelsons

“Nelsons Coldenza is a homeopathic remedy specifically designed to bring fast, effective relief for the symptoms of cold and flu.”

“Active [sic] ingredients: 6c homeopathic potency of Gelsemium sempervirens.”

“Precautions: Keep out of the reach of children. If symptoms persist or worsen, consult your doctor or homeopath.”

Needless to say there isn’t the slightest reason to think that these sugar pills will influence the course of a cold or flu. Thiis is not “information” for the patient.

It is misinformation.

It is lies, endorsed by the MHRA. Take a look at Ben Goldacre’s comments on this.

Who is responsible for this farce?

MHRA staff are listed here. My latest information suggests, though, that the MHRA were acting under instructions from the Department of Health, and the Executive Board failed to resist bad instructions.

The Executive Board

Professor Kent Woods qualified in medicine from Cambridge in 1972, followed by higher clinical training in Birmingham and epidemiological training at Harvard School of Public Health. In 1984 he was appointed Senior Lecturer in Clinical Pharmacology at Leicester University, where he now holds a personal chair in therapeutics.

As CEO of the MHRA, he must take responsibility

For other members, see here.

The Agency Board

Professor Sir Alasdair Breckenridge , CBE, was most recently Professor of Clinical Pharmacology at the University of Liverpool. He has been Chair of the Committee on Safety of Medicines (CSM) since 1999, a role which he relinquished when he became chair of the MHRA on its creation in April 2003.

Professor Angus Mackay , OBE, is Mental Health Service Director / Consultant Psychiatrist at the Argyll and Bute Hospital.

Michael Fox has been Chief Executive of the Prince of Wales’ Foundation for Integrated Health since 1998.

Shelley Dolan has worked at the Royal Marsden NHS Trust since 1989, now as Nurse Consultant Cancer & Critical Care

Charles Kernahan is Chief executive of the National Kidney Research Fund, the leading organisation supporting research into renal disease in the UK. His career in healthcare products and service provision spans over 25 years, having held the positions of Vice President Marketing EMEA for ConvaTec (a division of Bristol Myers Squibb) and Group Managing Director for Allied Healthcare (UK) Ltd,

Garry Watts is a Chartered Accountant employed as Chief Executive of SSL International plc, an international healthcare company with a turnover of circa £540m,

Lisa Arnold is currently involved on a voluntary basis with RAFT, a medical research charity, both as a Trustee and on a consultancy basis. Prior to that she had more than fourteen years’ experience as a senior pharmaceuticals and healthcare marketing analyst in the investment banking sector,

So the group that is responsible for advising on whether or not medicines work consists of one pharmacologist, one psychiatrist, a representative of an organisation devoted to crackpot medicine, a nurse and three accountants/bankers/marketers with strong industry connections.

Perhaps that accounts for their bizarre decision. One can only assume that the one pharmacologist was outvoted. The MHRA now seems to regard its role as promotion of the “homeopathic industry”

The decision of the MHRA to allow indications to appear on the label of sugar pills was not required by European legislation. It was a decision of the MHRA by itself (or perhaps as a result of pressure from ministers?). Their discussion document says (with my comments)

“The industry as a whole will benefit from the opportunity to gain indications for products for which use within the homeopathic tradition can be demonstrated, but cannot currently carry indications.”

[what part of the MHRA’s brief says that it is their job to promote any industries?]

“Legislation enabling the products to be labelled with indications is also considered to be of significant benefit to patients.

[how does lying to patients benefit them?]”

“Reviewing the PLRs will provide an opportunity to rectify any cases where products are being marketed with inappropriate indications.”

[and who will decide what indications are ‘appropriate’ for pills that contain nothing whatsoever?]

Read the statement at Sense About Science, and sign it!

See more comments

The Times Doctors attack natural remedy claims
By Nigel Hawkes and Mark Henderson. They quote

“Professor Kent Woods, chief executive of the MHRA, said: “This is a significant step forward in the way homoeopathic medicines are regulated. Products will have to comply with recognised standards of quality, safety and patient information.””

Patient misinformation is more like it. There is NO reason to believe the claims that will now appear on labels!

BBC News “Michael Baum, emeritus professor of surgery at University College London said: “This is like licensing a witches’ brew as a medicine so long as the bat wings are sterile.”

Sense about Science quotes comments on the MHRA’s bizarre behaviour. Here are three examples.

Dr Evan Harris MP, Liberal Democrat Science Spokesman, said:
It’s wrong that this country’s medicines regulatory arrangements, which need to be scientific and rigorous, are being diluted and polluted by processes which allow ineffective products to be licensed as medicines without having to provide any scientific evidence of effectiveness. There are very tight standards for proper medicines for very good reasons ”the need to protect vulnerable consumers from exploitation.”

Professor David Colquhoun, Professor of Pharmacology, University College London
“The new government regulations allow claims to be made that sugar pills can treat illnesses when there isn’t a fragment of reason to believe the claims are true. This is simply government-endorsed lying.”

Professor Edzard Ernst, Professor of Complementary Medicine, University of Exeter
“This makes a mockery out of evidence-based medicine.”

The Department of Health seems to be responsible

On 1 October 2006 I had a reply from the MHRA (from Sue Harris, Assessment Team Manager, Licensing Division), in response to my question about how the decision was made.

“The decision to implement the National Rules Scheme was agreed by the Executive Board in response to the ministerial request and not by the Agency Board as the Agency Board does not have executive responsibility. The Chair and non-executive board members were not involved in the decision making process and the final decision was taken by the Minister.”

This certainly suggests that the MHRA made their bizarre decision on instructions from above (not, perhaps, surprising in view of the Minister of State’s views). It does not explain why the MHRA knuckled under and implemented a policy that is in direct contradiction to their mission.

“Drug regulators too seem unequal to their task.”

That was the opinion offered by the editor of the BMJ, Fiona Godlee, in editorial comment on an problems with suicide by patients on antideoressants, e.g that by David Healy. She wrote

“Drug regulators too seem unequal to their task. Critics focus on their close relationship with industry; their lack of transparency; and an emphasis on efficacy over patient safety, which favours industry”

Which? magazine (October 2006, pages 24-25) published an article, Drugs watchdog fails public, and quotes the MHRA as responding thus.

“our role is not to protect industry interests. We have a responsibility to ensure that regulation is designed to enable rather than hinder the development of new products that would improve health.”

Quite right too. But this claim stands in stark contrast with the MHRA’s “Explanatory Memornadum“, which says this (my emphasis).

“Although the development of national rules by Member States under Directive 2001/83/EC is optional, failing to introduce the scheme would inhibit the expansion of the homeopathic ndustry by the prevention of the development of new products with indications.”

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