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Changes Needed in New-Drug Evaluation Process

Last Updated: April 01, 2009.

The evaluation process for new drugs is overdue for an overhaul, which could provide benefits for the public and the pharmaceutical industry, according to a point-counterpoint commentary published online March 31 in BMJ.

WEDNESDAY, April 1 (HealthDay News) -- The evaluation process for new drugs is overdue for an overhaul, which could provide benefits for the public and the pharmaceutical industry, according to a point-counterpoint commentary published online March 31 in BMJ.

Silvio Garattini, M.D., of the Mario Negri Institute for Pharmacological Research in Milan, Italy, and a colleague write that a variety of factors have diminished the reputation of the drug industry, including suboptimal trial designs and outcome measures, and biased reporting of findings. Steps that could lead to a better return for the public's support of the drug industry include greater transparency in drug evaluation and requiring proof of added value from new drugs. A new Italian law that requires financial support from drug companies for independent clinical research may hold promise.

However, writes Michael Tremblay, Ph.D., of Tremblay Consulting in Kent, U.K., the Italian setup -- which draws money from a tax on companies' advertising budgets -- fails to acknowledge the bigger picture in which the industry operates, and doesn't encompass the industry's relationships with government and universities. Funding more independent trials doesn't solve the problem of bias and poor design on its own, he writes.

"Apparently, the Italian government did not feel compelled to view funding clinical trials as a priority for general taxation. By creating a hypothecated (dedicated) tax, however, the policy is based on weak legs: AIFA's [The Italian Agency for Drugs] ability to fund independent clinical trials now depends on a compulsory tax on discretionary advertising budgets, which can of course go down," Tremblay writes.

Abstract - Garattini
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Abstract - Tremblay
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