Healthy Skepticism Library item: 11422

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Publication type: news

PMCPA defends FT claims
PMLive.com 2007 Aug 31
http://www.pmlive.com/index.cfm?showArticle=1&ArticleID=5845

Full text:

The Prescription Medicines Code of Practice Authority (PMCPA) has defended itself against allegations of weakness in its methods of investigation in to pharmaceutical companies.

A report in the Financial Times has criticised the current system of self-regulation in the pharmaceutical industry.

One of the main points is that when the PMCPA is investigating ethical breaches by drugs companies, they talk to the firms themselves, but not to the complainants.

A case that was highlighted was an investigation into Roche’s marketing of the breast cancer drug Herceptin. The Guardian ran an article on March 29 2007 alleging that Roche, or its PR agency Ketchum, attempted to use a patient, Professor Jardine, as part of its marketing strategy.

The FT said ‘the PMCPA did not contact Professor Jardine to hear her version of events but instead simply accepted the word of Roche’.

However, in the PMCPA’s Code of Practice Review, the panel investigating the case did question the journalist who wrote the original article.

This journalist, as usual, was offered the rights of a complainant. When told of the decision that no breach of the Code was found to have been proved the journalist was informed of the right to appeal. The journalist did not provide any further information relating to the third party and no
appeal was lodged, said Heather Simmonds, director of the PMCPA.

Simmonds defends the current system, saying everyone concerned can be fully involved in the investigative process.

The current complaints procedure gives complainants and those given the rights of a complainant the choice of being fully involved in the process including the right to comment on pharmaceutical company submissions when cases go to appeal. The published detailed case reports show the robustness
of the current system, asserted Simmonds.

The PMCPA makes decisions on a balance of probabilities on the evidence submitted by the omplainant and respondent, similar to the adversarial court system.

The PMCPA thus does not approach parties other than the complainant or the respondent to provide information. The complainant and respondent may however submit evidence from third parties.

As with the civil courts, if a case depends on one party’s word against another and there is no supporting evidence, this may suggest, depending on the exact circumstances, that the case is not proved on a balance of probabilities.

According to the FT , the journalists and the complainants they cite have been powerless to rebut counter-claims made by pharma companies defending themselves.

Several pharma companies are said to be equally unhappy with the current system and complain that there have been cases where they have been scrutinised by the PMCPA more than once about very similar allegations.

The FT reports that some companies have expressed concern that following investigation by the PMCPA they may face further prosecution, relating to the same allegations, by other agencies such as the UK government¹s medicines regulator.

Under the PMCPA’s current system, companies may be publicly reprimanded and/or required to issue a corrective statement; they may also be suspended from the Association of the British Pharmaceutical Insustry (ABPI).

One suggestion is for the PMCPA to back up its rulings against companies that breach the code of practice with a system of fines.