Monsanto Roundup Lawsuit

Thursday, December 15, 2011

MHRA - More on the Mysterious "Ghost Specialists"




Following on from MHRA In Buck-Passing Specialist Cahoots, the MHRA have now replied to my series of questions. My follow up response can be seen at the foot of this post.


Dear Mr Fiddaman,

Thank you for your recent enquiry to the MHRA.

Our reply of 7 December did not include a reference number as we (in the Central Enquiry Point) only assign reference numbers to requests under the Freedom of Information Act, and to requests passed to our Information Scientists for interrogation of our licensing database. We do not always include a name against our responses because the Central Enquiry Point often channels input from relevant technical experts in the Agency to prepare answers to enquiries. Colleagues in other parts of the Agency have prepared the response to your questions. However, in case it helps, I have included my name on this response.

Responses to each of your specific questions follow some general remarks.

You comment on our learning module on SSRIs. As we have mentioned, the learning module is written for health professionals and it should be read in conjunction with other information which covers the diagnosis and management of the relevant conditions.

Health professionals regularly work with others to give patients the best possible care—where necessary they routinely contact specialist services either for advice or with a request to take over the care of a patient. Once a patient is referred to such service, the specialist will treat the patient and, if necessary, contact other specialists within the network. This mechanism for care applies throughout the NHS whether a patient needs surgery, has cancer or suffers from other physical or mental illness.

The following address your specific questions:

1. You, as a regulator, do not have a list of these so-called specialists yet, without any qualms or vetting them, you are advising doctor's to use their services. Why?

Healthcare in the UK is regulated by several bodies each of which has a specific remit. While this Agency regulates medicines and healthcare products, others register health professionals and set standards for their competence (http://www.chre.org.uk/regulators). It is the health professional regulators who are responsible for setting standards of competence in line with current health knowledge and technology.

2. If I were to ask my GP to consult the RCP and RCGP will they be able to give him a list of specialists in SSRI dependence and withdrawal that he can consult?

A general practitioner will be very familiar with accessing specialist mental health services. These specialist services can then ensure that the patient is cared for by a specialist with appropriate skills.

3. Do you not feel, as a regulator, that you should, at the very least, see what training these specialists have had in the field of SSRi withdrawal?

The MHRA cannot encroach on the role of health professional regulators specifically created to set the standards of behaviour, competence and education of health professionals. The MHRA’s remit and expertise is in the regulation of medicines and healthcare products, not education and training of health professionals.

4. You, at my request, also met with Professor David Healy who has acknowledged that there are a significant number of people on SSRi's that will never be able to stop. Have you relayed this information to healthcare specialists, do you agree with Professor Healy's advice or do you think the advice is wrong?

During our discussion with Professor Healy he was clear that the focus should be on highlighting to GPs that withdrawal reactions could be serious and prolonged in some patients and agreed that NICE and the BNF would be reasonable routes. We have liaised with both the BNF and NICE to stress the importance of highlighting the risk of withdrawal reactions in their respective publication and guidance. We provided input into the consultation for the most recent revision of the NICE depression guideline and have also inputted into changes to the section in the BNF on the risk of withdrawal reactions with SSRIs.

5. As I understand, you promised to liaise with Professor Healy should any more concerns arise re SSRi withdrawal. To my knowledge you have not liaised with him since your 2010 meeting with him. Why?

You are correct that we have not had further meetings with Professor Healy since 2010 but this is because no significant new data on the risk of withdrawal reactions and their management that alters our previous discussions has come to light since then and therefore further discussions have not been considered necessary.

1. What input did you receive from the pharmaceutical industry for your SSRI learning module?

No input was sought nor received from the pharmaceutical industry on the MHRA learning module on SSRIs. It was constructed by MHRA staff and drew on information and evidence in the public domain.

2. Please list any grants/funding you, may or may not have, received for your SSRI learning module.

The MHRA receives no external funding for this work. The material has been assembled by MHRA employees as part of their routine work and towards meeting the MHRA’s objective of providing information to healthcare professionals and promoting good practice in the safe use of medicines.

...and my response, sent today...



Follow-up questions to Ref: FOI 11/475

In reference to your 2nd para:

Health professionals regularly work with others to give patients the best possible care—where necessary they routinely contact specialist services either for advice or with a request to take over the care of a patient. Once a patient is referred to such service, the specialist will treat the patient and, if necessary, contact other specialists within the network. This mechanism for care applies throughout the NHS whether a patient needs surgery, has cancer or suffers from other physical or mental illness.

1. For the record, just so we are clear, are the MHRA suggesting that severe SSRi withdrawal can now be defined as an illness?

2. Do you have instances where a health care professional has sought the advice or requested for an SSRi withdrawal specialist?

3. You state that “It is the health professional regulators who are responsible for setting standards of competence in line with current health knowledge and technology” Have the MHRA liaised with health professional regulators to determine whether or not 'specialists' have the required qualifications in treating patients with severe SSRi withdrawal?

4. You state that “A general practitioner will be very familiar with accessing specialist mental health services. These specialist services can then ensure that the patient is cared for by a specialist with appropriate skills.” If I were to randomly select 10 healthcare practitioners and ask them if they could refer an SSRi withdrawal specialist to me and, for one reason or another, they could not provide me with any such specialist, would the MHRA then concede that there are, in fact, no SSRi withdrawal specialists with adequate training that can provide help for patients suffering severe SSRi withdrawal?

5. You state “The MHRA cannot encroach on the role of health professional regulators specifically created to set the standards of behaviour, competence and education of health professionals.” I disagree, if the MHRA are recommending specialists then the MHRA have a duty to patient healthcare that those specialists be adequately trained in the field of SSRi withdrawal. In essence, you are recommending a service that you do not know exists. In a nutshell, you are recommending to healthcare professionals to seek specialist advice from 'specialists' who have had no training or have received no guidelines to help patients suffering severe SSRi withdrawal.

6. You state “During our discussion with Professor Healy he was clear that the focus should be on highlighting to GPs that withdrawal reactions could be serious and prolonged in some patients and agreed that NICE and the BNF would be reasonable routes. We have liaised with both the BNF and NICE to stress the importance of highlighting the risk of withdrawal reactions in their respective publication and guidance.” With respect, the question was - 'You, at my request, also met with Professor David Healy who has acknowledged that there are a significant number of people on SSRi's that will never be able to stop. Have you relayed this information to healthcare specialists, do you agree with Professor Healy's advice or do you think the advice is wrong?' I'll ask again. Professor David Healy has acknowledged that there are a significant number of people on SSRi's that will never be able to stop. Do the MHRA agree with professor Healy's findings?

7. You state that the SSRi Learning module was “constructed by MHRA staff and drew on information and evidence in the public domain.”. Please list all references/evidences used.