Is Comparative-Effectiveness Going Too Far Too Soon?
In a recent New England Journal of Medicine article, researchers from Stanford University and the Veterans Affairs Palo Alto Health Care System propose that FDA require drug labels to state whether a product is superior to other products in its therapeutic field. I think this idea is going way too far when it comes to comparative-effectiveness information.
When consumers purchase a hamburger from McDonald’s, does the hamburger’s wrapping state that it “tastes significantly better” than a hamburger from Burger King? Of course not. That information is to be determined by the consumer and is an individual preference.
Now, I understand that drugs are not hamburgers—medication clearly has a more significant effect in our health and how our body functions. I also understand and support the push to increase comparative-effectiveness research so that patients as well as doctors have the best information about how a product may function compared with other available products. But including that information on every drug label out there seems a bit neurotic.
The Stanford-led team claims that such labeling would make clinicians, patients, and payers “less willing to pay more for a new treatment without proof that it improved health outcomes” and that the labeling would give manufacturers “an incentive to conduct much-needed active-comparator superiority trials.” The label might say something like, “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,” according to the NEJM article.
I get where the authors are coming from, but these types of labeling statements will only serve to confuse patients—many may assume the product is ineffective. And exactly who will decide whether one drug is more “superior” than another and what criteria will be used? This idea may push the pharmaceutical industry’s already excessive competition and lobbying efforts over the edge as they try to gain that “superior” wording.
The researchers note that new therapies tend to cost more than already existing drugs, even though they may not be more effective. In this case, I think it should be up to the doctor prescribing the medication to determine what the patient should take based on postapproval observational data.
If the authors’ proposal makes headway, it seems to me that only the “superior”-labeled products will end up on the drugstore and pharmacy shelves because no one would want to buy or take the non-superior products. Undoubtedly, these products would be far pricier than the deemed “less-superior” products. This possibility would undermine our ability to choose, to have options, and in my mind, that is not one of the lofty goals behind comparative-effectiveness research.
This post is missing the main point. Consumers can readily judge the taste of hamburgers because they have experience with hamburgers and taste is indeed a matter of perference. But most consumers do not have much experience with the medications they are prescribed and clinical effectiveness is not equal to taste and preference.
Worse, you have a very low opinion of consumers. Why should the reporting of two simple pieces of information be confusing? Consumers don’t understand the words superior or placebo? Come on!
I have a question for you. How much of Pharmtech’s funding comes from outside of the pharmaceutical industry?
Jay, Thank you for your comment. I agree with you that medications and consumer experience with their effectiveness are unique issues. My primary point in this post was to say that I hope comparative-effectiveness studies stick to the goal of providing doctors and patients with the best information available and that the research doesn’t start to “take sides” by outwardly promoting some products over others. Sure, consumers know the difference between superior and placebo, but there are numerous reports of consumers experiencing an adverse event because of over-dosage or mis-dosage–so even the clearest and best-intended labels may not work how industry and regulators intend them to work.
PharmTech is a subscriber-based publication. Advertising is separate from editorial content.