PMCPA defends FT claims

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 complainant 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 governmentπs
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.