english.prescrire.org > Positions > Regulatory issues > Demanding higher standards

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

Demanding higher standards

There are ever more reasons to demand high-quality information concerning the latest new drugs coming onto the market. To spare patients from exposure to unjustified adverse effects. To force pharmaceutical companies and drug regulatory agencies to shape up. And to cut down on waste at public expense.

The gap is widening. Constantly. On one side are the patients and healthcare practitioners, with high hopes for new drugs that bring real therapeutic advance. On the other side is the market, where there are ever fewer new products, of marginal benefit.

Pharmaceutical companies have several tricks up their sleeves to make old drugs look new again, and to nevertheless garner publicity for their drugs.

Thus, a series of narrow indications have been successively authorised: peginterferon alfa-2b or ribavirin for hepatitis C, or cytotoxic drugs (sorafenib) for some types of liver cancer, or bevacizumab for some types of bronchial cancer.

And the umpteenth fixed-dose combination of drugs that have long been available separately, such as adapalene + benzoyl peroxide for acne.

And yet another useless transdermal delivery system, such as the one for rivastigmine for Alzheimer's disease.

And another "protodrug", which is quickly metabolised into a well-known drug, such as temsirolimus, that is converted to sirolimus.

Sometimes these tired old methods result in a modest improvement in terms of quality of care (sorafenib, for example). But more often than not, the results of this tinkering unnecessarily expose patients to risks, as with bevacizumab or rivastigmine.

In fact, there are ever more reasons to demand higher standards, and to consider the latest market introductions "not acceptable ". To spare patients from exposure to unjustified adverse effects. To force pharmaceutical companies and drug regulatory agencies to shape up, now. And to cut down on waste at public expense.

Source: "Exigences utiles" Rev Prescrire 2008; 28 (297): 485.