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Drug companies break the rules

The GPC has warned GPs of 'huge confidentiality issues' over collaborations with drug companies after a serious complaint was upheld against Merck Pharmaceuticals.

The Association of the British Pharmaceutical Industry strongly criticised Merck for the actions of one if its representatives, who removed practice records and contacted patients by post.

The ABPI's Prescription Medicines Code of Practice Authority warned it was 'an extremely serious matter' and ruled a breach of clause two of its code - for 'bringing discredit upon the pharmaceutical industry'.

Dr Peter Fellows, chair of the GPC prescribing subcommittee, told Pulse: 'There are huge confidentiality issues. We're seeing it more and more where pharma companies are coming in now.'

He warned drug companies often tried to 'distance themselves' by involving sponsored nurses or pharmacists rather than reps directly.

'If it's a professional who has signed a declaration of secrecy there is less concern but there still is concern. I don't think it has been clarified in terms of ethics,' he said.

The Merck case is the latest in a series of high-profile cases in which drug companies have been censured.

The Merck rep had the consent of a GP at the practice in searching records for patients with low HDL-cholesterol following a visit to discuss lipid regulator Niaspan.

But the authority found the rep had failed to maintain a 'high ethical code' after a complaint from the head of medicines management at the PCT.

The authority did not accept the company's claim that the rep's actions were out of character, as he had 'instigated similar reviews at four other practices and thus such activity appeared to be part of his normal working practice'.

Dr Nick Clements, medicolegal adviser to the Medical Protection Society, said: 'The basic principle is if it is identifiable we must have a good reason or consent to disclose outside the health care team. Doctors need to be particularly careful where they may be aware that people are wearing two hats.'

Merck has started disciplinary action against the rep.

A spokesperson said: 'We issued a reminder to managers and representatives of the importance of obeying the code. Sometimes people can stray into areas because their understanding of the code is weak. Ignorance is no excuse and it is something we take very seriously.'

March 2004

  • GSK-sponsored nurse found to have changed prescriptions to include one of company's drugs.

October 2004

  • GSK censured after sponsored nurse produces diabetes guidelines as official local policy.
  • AstraZeneca criticised by RCGP for sending letters on sponsored clinics direct to patients.

April 2005

  • MHRA names and shames Wyeth for openly questioning its guidance.
  • APBI censures GSK for offering a 'pecuniary advantage' to switch drugs.

July 2005

  • Row breaks out after British Hypertension Society allows Merck Sharpe & Dohme to alter word order in its ABCD rules.

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