Opinion - Editorials

Clean up drug approvals

What do many pharmaceutical companies across the world do when the number of new molecules that get past human clinical trials and the regulatory approval process is in steady decline? They cash in on drugs that manage to pass all the hurdles and milk them even after the patent expires by evergreening them, a practice that drug companies have come to master over the years. Shockingly, some pharmaceutical companies have achieved the dubious distinction of getting certain dr ugs approved by the regulatory body even when the results of clinical trials are not completely favourable. The storyline and the modus operandi remain the same; only the players involved and the products are different. This comes out from a study done by the department of psychology at the University of Hull, United Kingdom, and reported in the journal PLoS [Public Library of Science] Medicine. Analysis of data, both published and unpublished, from all the clinical trials involving more than 5,000 patients of the new-generation anti-depressants — selective serotonin reuptake inhibitors (SSRI) — revealed that when compared with a placebo, the drugs did not produce “clinically significant improvements” in patients with mild or even severe depression. Even in the most severely depressed patients, where the drug appeared to be better than a placebo, it was “decreased responsiveness to placebo, rather than increased responsiveness to medication” that was responsible. The study serves as a grim reminder that thousands of patients may have been unnecessarily medicated.

The shock is that the U.S. Food and Drug Administration (FDA), which had access to all the data, approved the drugs in the first place. The FDI actually withheld from researchers (who had asked for the data under the Freedom of Information Act) nine of the 47 trials of anti-depressants; and all nine were failed trials. Drug companies are well known for cherry picking data from multicentric trials, and for multiple publication of such results. Such unethical publishing of results can be avoided only when registration of all trials, now optional, is made compulsory. Medical journal editors have taken the lead; many of them have come together to fight the malpractice by making trial registration mandatory before the start of the trials — if publication is to be considered. Researchers have gone one step further and shown how they can evaluate the real parameters of the approved drugs. When used correctly, such evaluation can serve as a powerful tool to uncover faulty approvals.

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