english.prescrire.org > Positions > Regulatory issues > Perseverance

Theme: Regulatory issues

Drugs regulatory bodies ought to be the public’s principal defence against medicines that are useless, unproven or downright dangerous. Yet regulators increasingly depend upon financing from the pharmaceutical industry itself.

Themes

Perseverance

New drugs are often introduced to the market while their clinical evaluation is still underway. Drug regulatory agencies and government organisations must work towards rigorous, long-term evaluation of new drugs: it’s a matter of public health, in the fullest sense of the word.

New drugs are often introduced to the market while their clinical evaluation is still underway. Two very different examples demonstrate this situation.

Many questions have arisen over the effects of the papillomavirus 6, 11, 16, 18 vaccine (Gardasil°), in terms of the incidence of cervical cancer and the duration of protection. It will take years to reach any firm conclusions, even if the data from initial trials are encouraging.

In the case of trastuzumab, the data available at the end of 2006 provided more information concerning its potential benefits, including as an adjuvant therapy for breast cancer, and on its cardiac toxicity, than when the drug was first marketed 5 years ago.

Although the benefits of systematic drug evaluation after the granting of early marketing authorisation have been confirmed, these evaluations are not always rigorously carried out, far from it.

In the United States, the Food and Drug Administration publishes an annual report on whether or not pharmaceutical companies have fulfilled their commitment to conduct additional clinical trials after marketing authorisation was granted. The results are disturbing: over half of the trials are never completed, and some are not even started. And when interim progress reports are available, around one third are incomplete.

In France, and in Europe in general, there is not yet the same degree of transparency as in the US concerning the fulfilment of post-market commitments. We must persist in asking for greater transparency. Pharmaceutical companies, drug regulatory agencies and government organisations must work towards rigorous, long-term evaluation of new drugs: it’s a matter of public health, in the fullest sense of the word.

Source: "Persévérence" Rev Prescrire 2007; 27 (280): 88.