What hope have the FDA of understanding mHealth?

The New York Times ran an interesting opinion piece earlier this week (written by Steven Woloshin and Lisa Schqartz, Professors of Medicine at the Dartmouth Institute for Health Policy and Clinical Practice and the authors of “Know Your Chances: Understanding Health Statistics”) reporting on how the Food and Drug Administration (FDA) “after 33 years of deliberation” finally announced last month the “rules requiring manufacturers to clarify how well sunscreens protect against UVB and UVA radiation — in other words, how well they actually work“. The authors next go on to detail how “the agency could help consumers understand something far more important: how well a prescription drug actually works“.

The authors (who obviously have much more insight into the speed with which this regulator is more likely to move at) suggest the following as the way to provide Doctors with “independent, plain-English facts about the medication”:

fact boxes, similar to those that appear on food packaging, in every ad drug makers produce and along with every package of medication they sell… …all this information in a standardized, easy-to-read format

I’m surprised by the lack of consideration of the mHealth opportunity here.

Patients:

Surely we all know how the cereal manufacturers have worked out how to mislead consumers into thinking their products offer more nutritional content than they do? Without considerable care there is so much potential for canny marketers to use these info boxes to simply reinforce DTC patient misinformation such that it would greatly outweigh any potential benefits.

Also we’re already in a situation where an appalling volume of medical information distributed to patients exceeds the average reading age of the population and the functional health literacy is all too often over estimated. I’m surprised there’s not more use of video here as yet another piece of unpersonalised paper really isn’t the answer to patient empowerment.

Doctors:

The article points out several of the issues that would present if the FDA tasked drug makers in this way:

Even doctors may have not have all the facts. The professional label — information for prescribers written by the drug maker and approved by the Food and Drug Administration — often fails to provide critical data about the benefit of drugs

With shelf lives of a few years I can imagine that in many instances this “critical data” isn’t even going to be available at the time of the design and sale of the medication.

For some drugs, the answer may not even appear in the medical literature, because the research on which the government bases its approval is not always published. And even when it is, journal articles sometimes selectively report results, particularly when the drug maker had a substantial role in the studies themselves. In any case, much of what is published appears in specialty journals that few doctors have the time or interest to read

In a world where Google has indexed 3.3 billion webpages I think we’re just throwing in the towel if we’re going to accept that Doctors don’t “have the time or interest to read” the clinical evidence that supports the expensive pharmaceutical treatments they’re offering.

To understand how such a box would work, consider Abilify, an antipsychotic drug with domestic sales of $4.5 billion in 2010, which is approved for a variety of disorders, including depression that is only partly responsive to another drug. According to an Abilify advertisement, “approximately two out of three people being treated for depression still have depression symptoms”; the ad then suggests that people ask their doctor about adding Abilify to their drug regimen. But, as is generally the case, the ad doesn’t tell them how well the drug works. And the professional label for doctors says only that the drug was “superior to placebo,” not by how much. These advertising and labeling practices are neither unusual nor unique to Abilify, and are in compliance with federal regulations. The box, on the other hand, would quantify the benefits and side effects of Abilify used in combination with other antidepressants, drawing on the larger of the two six-week trials that formed the basis of its approval by the F.D.A. First, it would show how the drug scored versus a placebo (in Abilify’s case, not much: only three points lower on a 60-point scale, and it resolved depression for only 10 percent of patients — that is, 25 percent with Abilify versus 15 percent with just the placebo). The box would also highlight Abilify’s most important side effects: it caused 21 percent of patients in the trials to develop akathisia, or severe restlessness, and 4 percent to gain a substantial amount of weight. And, as with all anti-depressants, there is a small increase in suicidal thoughts and behavior among many young adults

I wonder if the authors even considered that the end result would probably just be more of this:

Surely this example also reinforces the pointlessness of throw away out of date printed documents as prescribing tools for Doctors? In this case we are after all talking about a prescription that costs >$1000 per course.

Are the benefits worth the side effects? That’s a decision for individuals to make with their doctors. But the only way they can come to an informed decision is by seeing the data. Otherwise, they can only guess — and studies show that they usually guess wrong, assuming that drugs work really well for everyone. Indeed, a section of last year’s health care reform law required the Department of Health and Human Services to review the evidence on drug fact boxes and file a report to Congress to recommend requiring them or not. But in its one-year report, filed in March, the department declared that it needed at least three more years to come to a decision

Considering the length of the decision making process and that as many as 90% of US Doctors already have a smartphone, maybe it would be better for everyone if the US Regulators simply mandated that as of 2012 every prescribing Doctor must work with unshared access to an up to date drug reference resource and be enlisted so that they receive safety alerts.

Ignoring the additional patient safety benefits I wouldn’t be surprised if the provision of the smartphones and the content was also much cheaper than the costs of developing and enforcing the drug fact boxes.

About 3G Doctor

The Corporate Blog of 3G Doctor
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