Predicting drug disasters
Seema Singh -
Sunday, August 03, 2008 6:27 PM
One of the most stringent drug regulatory authorities in the world, the US Food and Drug Administration, comes under flak for having fatal flaws in the way new drugs are tested and marketed. This time it’s no patients’ advocacy group but a sociologist and professor of comparative health at the University of Medicine and Dentistry of New Jersey. Presenting his new study “Institutional Foundations of the Vioxx Disaster” at the annual American Sociological Association meeting today, Donald Light says: “Drug disasters are literally built into the current system of drug testing and approvals in the United States. Recent changes in the system have only increased the proportion of new drugs with serious risks”
Light says instead of using current approved drugs as benchmarks of efficacy, the existing testing system evaluates the effectiveness of new drugs against placebos. Systematic reviews, he argues, indicate that one in seven new drugs is superior to existing drugs, but two in every seven new drugs result in side effects serious enough for action by the FDA, including black box warnings, adverse reaction warnings, or even withdrawal of the drug.
Based on this system, Light asserts that new drugs are twice as likely to harm patients as to provide them with benefits superior to existing drugs. Adverse drug reactions are the one of the top 5 causes of death and hospitalization and can occur for a number of reasons, including improper prescribed dosage, drug abuse and drug interactions. But when it comes to India, the less said the better as the industry and the regulatory system hardly report any such event. The ‘archive’ section on the regulator’s website doesn’t work, so you can’t check out some ADRs that have been reported. While Light accuses the industry of designing flawed clinical trials to get “desired results’, the government oversight, he says comes from “under-funding of the FDA”. This creates a dependency on the pharmaceutical industry — the industry FDA regulates—to pay its staff. In return for drug company funding, Light says, the industry expects faster reviews, but faster reviews potentially fail to identify serious long-term side effects. What do we say of the Indian regulatory system, which is even more dependent on the industry? A senior pharma executive from Mumbai once told me that when his company submitted papers for a new clinical trial approval (of a new molecule), he was asked by the regulatory agency for the names of experts who it could consult to review the application!