York study finds latest drugs may not always be better

A bottle of pills

Buyer beware: “Newer” rarely means “better” when it comes to the latest prescription drugs, according to a York University study.

The study, recently published in the journal Health Policy, looked at the benefits of new drugs compared to options already available to consumers. It found that “newer” only really means “better” about 10 per cent of the time.

Dr. Joel Lexchin“In determining whether a new drug is really a better option, it’s important to assess three aspects: Does it work better than those we already have available? Is it safer? Is it more convenient?” says Dr. Joel Lexchin (left), a professor in York University’s School of Health Policy & Management, Faculty of Health.

“Despite all the talk from the pharmaceutical industry about how many innovative drugs it produces, when these drugs are evaluated after they’ve been on the market, very few make any difference to patients,” he says.

The study reports that between 2004 and 2009, Health Canada approved 144 new drugs; of these, 34 per cent were given a “priority review”, meaning that Health Canada felt they were innovative. In the United States, a greater percentage of drugs were given an “innovative” rating by the Food and Drug Administration. However, once drugs are actually on the market and are being widely used, very few turn out to be innovative, the study finds. Only 12 out of 120 were rated innovative by Canada’s Human Drug Advisory Panel (HDAP). Similarly, 92 per cent of more than 600 drugs reviewed by Prescrire International, an independent drug bulletin in France, were classified as non-innovative.

“In other words, only about 10 per cent of the new drugs coming out have any real benefit to consumers over the drugs they may already be using. The vast majority don’t have any significant benefits in terms of efficacy, safety or convenience,” says Lexchin.

While HDAP and Prescrire International agree on the percentage of drugs that qualify as therapeutically innovative, they don’t always agree on the products themselves, the study finds. A drug-by-drug comparison showed their rate of agreement as “fair”, at 83 per cent.

“The importance of these differences between the various agencies is not which agency is right and which is wrong, but rather why these differences exist and what the policy implications may be,” Lexchin says.

He says changes in pharmaceutical policy should be explored in three areas: transparency in disclosure of information; whether harmonization of drug regulation across national boundaries is always beneficial; and how clinical practice guidelines are developed.

“If drug regulatory bodies like Health Canada and the FDA can’t agree on what’s innovative, then Canada needs to seriously rethink how much we want to harmonize our regulatory system with that of the US,” he says.

In the meantime, what can consumers do to protect themselves from being caught up in the marketing hype? Lexchin advises that when consumers visit their doctors and get a prescription, they should not automatically assume that newer is better. If their doctor wants to use a newer drug, then they should be sure that the doctor has good evidence that it’s superior.

In addition to his role at York, Lexchin is associate professor in the Department of Family & Community Medicine at the University of Toronto and an emergency physician with the University Health Network (UHN).