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post-commercialization trials for a better quality of life

07 - 29 - 2002 dans Action 81

The anti-HIV drugs we daily take came on the market long ago : in 1987 for AZT, and in 1996 for the protease inhibitors. The laboratories undertook the 3 necessary tests before the drugs were allowed to be distributed : phase 1, which concerns biological and clinical resistance, toxicity and dosage ; phase 2 - medical efficacy and optimal dosage ; and phase 3 - often a comparative study of the effective results of the drugs, including side effects... At the end of this third study permission to distribute the drugs is granted.

The drugs can then be prescribed by doctors. In the meantime, the knowledge of the side effects of these drugs has to be explored more thoroughly through the experience of doctors, the pharmaceutical industry and the CRVP (the local drug vigilance agency). Our experience shows that these side effects are not well-known, rarely taken in consideration by doctors, often badly reported by the global drug-vigilance system, and not closely followed by the laboratories.

Drug-vigilance must be more pro-active. Patients and doctors need to be aware of the long term effects, either positive or negative, in the conditions in which actual patients regularly take these drugs, in REAL LIFE, and not only the hypothetical environment of the laboratories.We are pushing to obtain a fourth phase, to study the long term effects of drug treatment. Piloted by AIDS organisations over a long period of time, these tests could give us a more accurate knowledge of the drugs, and their conditions of use, to collect more substantial information about possible previously unidentified toxic or other side-effects. These tests would constitute a long term study of the use of these drug combination therapies, based on the experience of patients.

However, the laboratories continue to be purposefully vague about the terminology of this fourth type of test : they claim to carry out such tests already, because in the drug companies, any study on a molecule that obtains a commercialization permit is taken as the fourth phase. Mostly, these tests are carried out as part of the marketing procedure, ignoring any medical perspective on the drugs, or questions of maximal dosage or clinical strategy.

At the present, only independant study groups, public or private, are carrying out these vital post-commercialization studies, providing us with additional information on the molecules after their commercialization.

Each time we address this issue with the AFSSaPS , they reply that their only legal power is to suspend the commercialization permit, which is exactly what we do not want. The public sector seems unable to create a coherent legal framework. This is why we are asking these studies, financed by the drug industry, to be undertaken by independant organisations. This would mean a more accurate evaluation by drug associations and would avoid conflicting interests. We ask the laboratories to be obliged to finance such trials, managed by a state organization.

We are constantly pressing the drug companies to undertake such trials, without any degree of success. We INSIST that the public sector, including the AFSSAPS, uses legal means to obtain these studies, in order to improve the health of HIV-positive people on drug combination therapies. As clinical strategy become more and more complex and the period of time over which these drugs are being administered is getting longer, these studies are essentials in order to improve the quality of life for people whom well-being depends on these drugs. These tests should have been put into place at the time of the first combination-therapy drugs treatments ; this didn’t happen. Today, the most urgent thing is to force the drug industry and the public sector to care about the long-term effects of drug treatment therapies.

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