Drugs licensing flaws exposed

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Mon, 4 Oct 2004 20:24:56 -0400

 

 

Drugs licensing flaws exposed

http://society.guardian.co.uk/print/0,3858,5030703-105965,00.html

 

Drugs licensing flaws exposed

 

Special report Pfizer advised on how to get antidepressant approved by

member of body deciding on application

 

Sarah Boseley

Monday October 4, 2004

The Guardian

 

A leading figure in the world of psychiatry gave a pharmaceutical

company advice on how to get its new drug approved while he was

sitting on the committee which was deciding the licence application.

An internal memorandum from Pfizer, the world's largest drug company,

says Stuart Montgomery would be happy to become a paid adviser and

declare an interest to the Committee on the Safety of Medicines (CSM)

once the drug, an antidepressant to rival Prozac, had been through the

licensing process. The drug, sertraline, which acquired the brand name

Lustral, became a billion-dollar success, but is now one of several

banned from use in children in the UK because of evidence they can

cause them to become suicidal. Their use in adults is under

investigation. Dr Montgomery says his ad vice to Pfizer in 1989 was

permissible because he was not receiving money from the company at the

time. But Kent Woods, chief executive of the drug regulatory body

which grants licences on the advice of the CSM, said such conduct was

" absolutely unacceptable " . " Not only does each member [of the CSM] on

appointment sign a letter ensuring confidentiality but at every

meeting, the chair as a matter of routine reminds everybody that

proceedings are confidential, " he said. If the company had questions,

they should have talked to officials of the Medicines and Healthcare

products Regulatory Agency (MHRA), not the independent CSM experts.

Critics say the case exposes weaknesses in the drug licensing system,

run by a regulatory body which, other papers obtained by the Guardian

reveal, has an unquestioning relationship with drug companies. That

relationship is so close that the pharmaceutical trade body in June

drew up a business plan for the regulator, concluding: " Our priorities

are aligned. " In the first of a two-part investigation into the

influence of the drug companies over doctors and government, the

Guardian examines the intimacy between the industry and the regulator.

.. Tomorrow it will focus on the sponsorship, consultancies and fees

paid to doctors by drug companies.

 

The MHRA is responsible for licensing medicines and regulating the

industry. It relies on the advice of the independent experts on the

CSM when it grants a new product licence. These experts, from all

fields of medicine, are supposed to declare any pharmaceutical company

interests, such as consultancies, fees and shareholdings, and must

leave the room when drugs from com panies that have paid them are

discussed. During his time on the CSM, Dr Montgomery disclosed

payments for lectures and advice from Eli Lilly, the makers of Prozac,

and from Organon, Beecham, Merck, Sanofi, Glaxo, Novo, Jouveinal,

Duphar, Wyeth and Almirall. Dr Montgomery, who held a joint post with

St Mary's hospital, Paddington, and Imperial College in London, was a

psychiatric expert on the CSM. His opinion was crucial in 1989, when

the Medicines Control Agency as it was then known was considering an

application from Pfizer for a licence for sertraline.

 

A confidential internal memorandum from Pfizer, dated April 24 1989,

which was submitted in evidence to a recent court case in the US, has

been obtained by the Guardian together with Mind, the national

association for mental health, which has been campaigning for better

drug regulation. Richard Brook, its chief executive, will today call

for an external inquiry. " There is clear confusion about the role that

Dr Montgomery was playing in this situation, " he said. " It also makes

it very difficult for outsiders to believe there was not a serious

conflict of interest when one of the major experts on depression

involved in the CSM is actually speaking to a drug company about how

they best present their results for licencing. " Dr Montgomery became a

professor of psychiatry at Imperial College in 1993. The journal he

edits, International Psychopharmacology, regularly publishes

company-funded studies of antidepressants, as other journals do. He

authors many of the papers, often jointly with other senior figures in

the field. The memo reveals that Dr Montgomery met Pfizer officials at

St Mary's. He told them the committee had accepted that the drug was

effective but " the safety analyses require re-presentation " and he

advised them how to go about it. He told Pfizer they must appeal

against the CSM's initial decision. The memo reveals that Dr

Montgomery is not going to declare an interest in Pfizer.

 

" He would still like to remain a disinterested party at the CSM till

the appeal was heard, " says the memo. " Thereafter he would be happy to

act as an adviser to Pfizer and declare an interest. " The Pfizer drug

got its approval first in the UK. Other European regulators were not

happy that the data from clinical trials proved it worked. Dr

Montgomery said he had no conflict of interest over Pfizer. " My

comments to Pfizer in 1989 were the usual clarification of the

objections of the CSM to their application. At that time I had no

conflict of interest with Pfizer, I was not a paid consultant, I was

not in receipt of research grants from Pfizer, and I did not own

shares in Pfizer, " he said in an email to the Guardian. " The extracts

from the memorandum make it clear that I was a disinterested party and

was not prepared to consider a relationship with Pfizer while an

application was under review. "

 

SocietyGuardian.co.uk © Guardian Newspapers Limited 2004