Sarah Boseley, health editor
Guardian

Thursday December 28, 2000

http://www.guardian.co.uk/Archive/Article/0,4273,4110246,00.html

A top executive at one of the world's leading pharmaceutical companies is to become director of drugs licensing at the medicines control agency, raising questions about the independence of the MCA from the industry that it is supposed to police.

Ian Hudson will take up his new job in February. He has worked in the drugs industry for the past 11 years and until recently was director and vice- president of Worldwide Clinical Safety, at SmithKline Beecham, and was to have led the worldwide drug safety group after the merger of SKB with Glaxo Wellcome, which came into effect yesterday.

The MCA rebuts any suggestion that the appointment of Dr Hudson to head the drugs licensing division will reinforce the already close links between the MCA and the drugs industry.

"These very senior positions within the agency do not come along very often and it would be regarded as an exceptional opportunity to play a leading national and international role in public health through medicines regulation," said a spokeswoman. She added that the MCA had "previously attracted high-calibre candidates from industry", including its chief executive, Keith Jones. Dr Jones was formerly a director of Merck, Sharpe and Dohme Rahway in the United States.

But there will be concerns over the appointment among consumer groups and those who are critical of the MCA's secretive ways of operating.

Although the MCA claims to be moving towards greater openness, few details have been divulged about evidence given that has meant approval or otherwise for drug licences.

The agency argues that the data it sees from clinical trials are commercially sensitive and must be kept secret to assure protection from competitors to the companies developing the drugs.

The MCA makes its decisions following advice from the committee on safety of medicines, a group comprising doctors and scientists, the majority of whom have links to the drugs industry in the form of research grants, consultancies or other financial support.

All members of the CSM are asked to declare both personal interests in drug companies, such as shares or fees, and non-personal interests, such as funding for clinical trials. Any member with a personal financial interest is expected to leave the room when the CSM starts to discuss drugs connected with the company involved.

Critics say, however, that the problem runs deeper than personal interests because most of the scientists are steeped in a culture which does not tend to question the drugs industry.

Paul Flynn, MP for Newport West, considers this culture "defensive, pro-industry and anti-consumer". He says that those responsible for advising and granting licences for medicines should be wholly independent of the industry and rejects the argument that the scientists who are employed and backed by drugs companies are the best in their field.

"They tell you these people are the only ones who can do it, which is not true. There are plenty of independent people who could do it," he said.

While it was not uncommon for top figures in other industries to move into Whitehall, such as the Department of Trade, he said, "matters of life and death" hung on decisions that affected the licensing of medicines.

Clare Mackay, principal policy adviser to the Consumers' Association, said it was probably inevitable that there would be movement between the industry and the regulatory body. She said the issues were about conflicts of interest when people "crossed over", and the need for guidelines to be in place to manage it. Also his appointment sent out a message about "the priorities for the MCA".

The drugs regulatory system is facing a review within Europe which may lead to the end of separate licensing bodies for countries. Ms Mackay said she was aware that it would be a challenge to get the public/patient perspective taken on board.