Drug approval “innovative” : the FDA is it too flexible ?

This is a trend that can be observed since several years at the two main Agency of medicines global, european and american (FDA). The desire to accelerate the placing on the market of medicines called “innovative”. This allows, in theory, to run more quickly of the drugs to cover unmet needs in serious illness, while bringing significant benefits compared to the risks. It is also a procedure which is appreciated by the industry, who hope to market their treatments as soon as possible. In order to benefit longer from the protection of the patent (twenty years from the patent filing during the discovery of the molecule).

Drugs lack evidence of efficicence

An article published this week in the Journal of the American Medical Association (Jama), a medical journal, is interested in the practices of the FDA in studying the 22 drugs, including 19 against the cancer, who have received an accelerated approval between 2009 and 2013. Result : for the medical journal, the lack of evidence of safety and effectiveness of these treatments is urgent. The effectiveness of eight drugs approved for five years or more has not yet been confirmed.

Thus, the fourteen procedures of approvals accelerated were based solely on studies less rigorous than those for the approval of a standard treatment, ” says the report. Some did not follow the procedures of randomized controlled trials, that is to say, the random allocation of patients in the group receiving the new treatment, and the placebo group or those receiving a standard treatment. Clearly, these clinical studies did not show specifically whether the treatments were more effective than the existing ones. In addition, the FDA claimed, therefore, studies post-approval. But only half of the 38 required have been carried out to date. Less than 50% of the 22 drugs that have replied to the satisfaction of the FDA. No consequence for these treatments present on the market, for the time being.

The importance of post-marketing studies

The Jama not accusing the FDA to give the green light to the drug to be ineffective. But he gives credit to the criticism of the elders of the FDA, who felt the american Agency of drugs too flexible. Like David Gortler, who denounced and in 2016 the weakness of some clinical tests.

The medical journal reminds us that the Agency makes mandatory a study of post-marketing for drugs that entered more quickly on the market, proving their efficiency. In the contrary case, the processing may exit the market. This was the fate suffered by the gemtuzumab, Pfizer against myeloid leukemia, in 2010.

Without post-market study, for example, it is difficult to realize the actual effectiveness of a treatment. For example, the patients selected in clinical trials are generally younger than in reality for the cancer and often less sick. However, an elderly patient is likely to face serious adverse effects, in particular when it is receiving anticancer. It is therefore more likely to receive different doses, and a treatment made differently is less effective. Or, a patient may be suffering from other diseases which is not the case of those recruited in clinical trials in general.

In the clear, as explained in the NCBI, us national institute for biological information, molecular, it is not known, even with procedures for randomized clinical trials, if the treatment is for a specific type of patient or for all patients. Thus, some treatments for which clinical studies cite up to ten months of survival further, prolong the life of less than five months in reality. With studies in the real world and the clinical results recorded, without criteria inclusions drastic, it is possible to see if the treatment works for all patients.

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