Wendy Woflson
Newswire21.org

New drugs generally cost more than older drugs, but do they really work better? What if you could find out just by reading the label? 

In a perspectives piece just published in the New England Journal of Medicine, a group of medical researchers from Stanford University propose comparative labeling of new drugs. This could help consumers, doctors, and payers better evaluate drugs as they come on the market. 

Currently, the FDA requires drugmakers to show their products are safe and effective. A new drug has to show it works better than existing medications only when it is clearly unethical to withhold active treatments from patients, for example in studies of AIDS or cancer.

Often new drugs get approved just because they demonstrate that they work better than placebo. The bar for medical devices is even lower.

From the drug developer's point of view, placebo trials are cheaper than trials actively comparing drugs to competitors, as they can be done on a smaller scale. There are also less chance of being surprised by unfavorable results. And a drug developer doesn't run the risk that two pretty much identical drugs would both be no better than placebo.

However, placebo trials don't give much useful information on how effective a drug is in comparison to products already out there. And if comparative information is scanty, then drug companies can market a new drug as an improvement on the earlier generation of treatment. Ambiguity doesn't however, give incentive for real innovation.

Same Ol' Results
According to the Stanford trio -  Drs. Randall Stafford, Todd Wagner, and Phillip Lavori,  if a drug label were to say, for example, "Although this drug has been shown to lower blood pressure more effectively than placebo, it has not been shown to be more effective than other members of the same drug class," then a payer could determine what is clinically effective and negotiate on price. Developers would then have to distinguish their drugs based on effectiveness.

But some would say that determining clinical effectiveness is out of the FDA's bailiwick. The authors suggest that large government or private payers, instead of the drug developers, could conduct comparative effectiveness trials. 

Alternatively, a national center for comparative-effectiveness research could be established to conduct large meta analyses and prospectively collect observational data once a drug is out on the market. This could serve as a resource for physicians.

"The goal is to shift the function of the drug market so that patients and physicians focus on comparative information about outcomes rather than surrogate measures (or even worse, attributes like capsule color)," said Stafford.

Just Rewards
"For manufacturers, there would be less gain for new me-too drugs, but more to gain from new drugs that prove superior to existing products," he said. "Manufacturers with me-too drugs that are at best equivalent to what's available already will find that the suggested labeling requirements hamper their drug promotion efforts.

"On the other hand, the company that invests to develop a better drug will benefit enormously from the suggested changes in labeling," Stafford continued. "For this company, the labeling requirements become something like government-mandated and -approved drug marketing."

The doctors run the risk of biting the hands that feed them. Stafford disclosed that he's received grants from Procter&Gamble and Toyo Shinyaku.  Wagner received support from American Medical Systems. And. Lavori collected consulting fees from Neuronetics, Corcept, Fibrogen, Depomed, DLA Piper and ARCA Biopharma.