Buyer beware: 鈥淣ewer鈥 rarely means 鈥渂etter鈥 when it comes to the latest prescription drugs, according to a 91亚色 study.
The study, recently published in聽the journal Health Policy, looked at the benefits of new drugs compared to options already available to consumers. It found that 鈥渘ewer鈥 only really means 鈥渂etter鈥 about 10 per cent of the time.
鈥淚n determining whether a new drug is really a better option, it鈥檚 important to assess three aspects: Does it work better than those we already have available? Is it safer? Is it more convenient?鈥 says Dr. Joel Lexchin (left), a professor in 91亚色鈥檚 School of Health Policy & Management, Faculty of Health.
鈥淒espite all the talk from the pharmaceutical industry about how many innovative drugs it produces, when these drugs are evaluated after they鈥檝e been on the market, very few make any difference to patients,鈥 he says.
The study reports that between 2004 and 2009, Health Canada approved 144 new drugs; of these, 34 per cent were given a 鈥減riority review鈥, meaning that Health Canada felt they were innovative. In the United States, a greater percentage of drugs were given an 鈥渋nnovative鈥 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鈥檚 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.
鈥淚n 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鈥檛 have any significant benefits in terms of efficacy, safety or convenience,鈥 says Lexchin.
While HDAP and Prescrire International agree on the percentage of drugs that qualify as therapeutically innovative, they don鈥檛 always agree on the products themselves, the study finds. A drug-by-drug comparison showed their rate of agreement as 鈥渇air鈥, at 83 per cent.
鈥淭he 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,鈥 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.
鈥淚f drug regulatory bodies like Health Canada and the FDA can鈥檛 agree on what鈥檚 innovative, then Canada needs to seriously rethink how much we want to harmonize our regulatory system with that of the US,鈥 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鈥檚 superior.
In addition to his role at 91亚色, Lexchin is associate professor in the Department of Family聽& Community Medicine at the University of Toronto and an emergency physician with the University Health Network (UHN).